News Archive of FDA Drugs- What\'s New

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Comunicado de la FDA sobre la seguridad de los medicamentos: La FDA refuerza las advertencias y cambia las instrucciones de prescripción para reducir el riesgo de sufrir reacciones alérgicas graves con el medicamento para la anemia Feraheme (ferumoxitol)04-02-15
CDER Key Officials List04-01-15
FDA Drug Safety Communication: FDA strengthens warnings and changes prescribing instructions to decrease the risk of serious allergic reactions with anemia drug Feraheme (ferumoxytol)03-30-15
Comunicado de la FDA sobre la seguridad de los medicamentos: La FDA advierte de una reducción grave de la frecuencia cardiaca cuando se usa el medicamento antiarrítmico amiodarona junto con tratamientos contra la hepatitis C que contienen sofosbuvir (Harvoni o Sovaldi), en combinación con otro fármaco antivírico de acción directa03-26-15
FDA Drug Safety Communication: FDA warns of serious slowing of the heart rate when antiarrhythmic drug amiodarone is used with hepatitis C treatments containing sofosbuvir (Harvoni or Sovaldi) in combination with another Direct Acting Antiviral drug03-24-15
FDA Drug Safety Communication: FDA review of study sheds light on two deaths associated with the injectable schizophrenia drug Zyprexa Relprevv (olanzapine pamoate)03-23-15
Comunicado de la FDA sobre la seguridad de los medicamentos: La FDA actualiza la etiqueta del medicamento para dejar de fumar Chantix (vareniclina), para incluir la posible interacción con el alcohol, un riesgo poco común de sufrir convulsiones, y los estudios de efectos secundarios en el estado de ánimo, la conducta o el pensamiento03-16-15
FDA Drug Safety Communication: FDA updates label for stop smoking drug Chantix (varenicline) to include potential alcohol interaction, rare risk of seizures, and studies of side effects on mood, behavior, or thinking03-09-15
Clinical Trial Imaging Endpoint Process Standards03-04-15
FDA Drug Safety Communication: FDA cautions about using testosterone products for low testosterone due to aging; requires labeling change to inform of possible increased risk of heart attack and stroke with use03-03-15
FDA Drug Safety Communication: FDA requires label warnings to prohibit sharing of multi-dose diabetes pen devices among patients02-27-15
Safe Use Initiative05-20-14
Comunicado de la FDA sobre la seguridad de los medicamentos: Estudio de la FDA de pacientes de Medicare encontró menor riesgo de derrame cerebral y muerte con Pradaxa (dabigatrán) en comparación con warfarina05-16-14
FDA warns of next-day impairment with sleep aid Lunesta (eszopiclone) and lowers recommended dose05-15-14
FDA study of Medicare patients finds risks lower for stroke and death but higher for gastrointestinal bleeding with Pradaxa (dabigatran) compared to warfarin05-13-14
FDA permits manufacturers of oral health care benzocaine products to include a methemoglobinemia warning05-13-14
FDA Provides Facts About Zohydro04-30-14
FDA requires label changes to warn of rare but serious neurologic problems after epidural corticosteroid injections for pain04-23-14
Comunicado de la FDA sobre la seguridad de los medicamentos: la FDA aclara el uso pediátrico de Revatio (sildenafil) para la hipertensión arterial pulmonar04-01-14
FDA clarifies Warning about Pediatric Use of Revatio (sildenafil) for Pulmonary Arterial Hypertension03-31-14
Opioid Patient-Prescriber Agreement03-07-14
FDA approves label changes for antibacterial Doribax (doripenem) describing increased risk of death for ventilator patients with pneumonia03-05-14
How to Report a Shortage or Supply Issue02-14-14
Comunicado de la FDA sobre la seguridad de los medicamentos: La FDA analizará el riesgo de insuficiencia cardiaca con el medicamento para la diabetes saxagliptina (comercializado como Onglyza y Kombiglyze XR)02-12-14
FDA Drug Safety Communication: FDA to review heart failure risk with diabetes drug saxagliptin (marketed as Onglyza and Kombiglyze XR)02-10-14
Comunicado de la FDA sobre la seguridad de los medicamentos: La FDA evalúa riesgo de derrame, ataque cardiaco y muerte por usar productos con testosterona aprobados por la FDA02-06-14
FDA evaluating risk of stroke, heart attack and death with FDA-approved testosterone products01-31-14
NDC Database File (Zip Format)01-27-14
Comunicado de la FDA sobre la seguridad de los medicamentos: La FDA advierte de posibles efectos adversos por exceder la dosis recomendada de productos de venta libre que contienen fosfato de sodio para el tratamiento del estreñimiento01-13-14
FDA Drug Safety Communication: FDA requires multiple new safety measures for leukemia drug Iclusig; company expected to resume marketing12-26-13
Comunicado de la FDA sobre la seguridad de los medicamentos: Sucesos adversos graves resultantes de ingestión accidental por niños de colirios (gotas para los ojos) y aerosoles nasales de venta libre12-26-13
FDA Drug Safety Communication: FDA warns of rare risk of long-lasting erections in males taking methylphenidate ADHD medications and has approved label changes12-26-13
FDA Drug Safety Communication: FDA warns of rare risk of long-lasting erections in males taking methylphenidate ADHD medications and has approved label changes12-18-13
Current Drug Shortages Index12-18-13
Comunicado de la FDA sobre la seguridad de los medicamentos: FDA advierte de graves reacciones de la piel con el medicamento anticonvulsivo Onfi (clobazam) y ha aprobado cambios a la etiqueta12-09-13
FDA Drug Safety Communication: FDA warns of serious skin reactions with the anti-seizure drug Onfi (clobazam) and has approved label changes12-03-13
Comunicado de la FDA sobre la seguridad de los medicamentos: FDA requiere que se eliminen ciertas restricciones al recetar y dispensar medicamentos para la diabetes que contienen rosiglitazona11-29-13
Comunicado de la FDA sobre la seguridad de los medicamentos: La FDA advierte de riesgo poco común pero grave de ataque al corazón y muerte con los medicamentos Lexiscan (regadenoson) y Adenoscan (adenosina) para la prueba nuclear de esfuerzo cardíaco11-25-13
FDA significantly restricts access to the diabetes drug Avandia11-25-13
FDA Drug Safety Communication: FDA requires removal of some prescribing and dispensing restrictions for rosiglitazone-containing diabetes medicines11-25-13
FDA warns of rare but serious risk of heart attack and death with cardiac nuclear stress test drugs Lexiscan (regadenoson) and Adenoscan (adenosine)11-20-13
Comunicado de la FDA sobre la seguridad de los medicamentos: La FDA solicita cambios a la etiqueta y empaque de uso único para productos antisépticos tópicos de venta sin receta médica para disminuir el riesgo de infección11-19-13
FDA Drug Safety Communication: FDA requests label changes and single-use packaging for some over-the-counter topical antiseptic products to decrease risk of infection11-13-13
Comunicado de la FDA sobre la seguridad de los medicamentos: Recomendaciones actualizadas para disminuir el sangrado de la columna vertebral y parálisis en pacientes que usan heparinas de bajo peso molecular11-13-13
Comunicado de la FDA sobre la seguridad de los medicamentos: Suspensión de ventas y mercadeo de Iclusig (ponatinib): Instrucciones para profesionales de la salud sobre cómo obtener acceso de emergencia a Iclusig para los pacientes que responden a él11-12-13
FDA Drug Safety Communication: Updated recommendations to decrease risk of spinal column bleeding and paralysis in patients on low molecular weight heparins11-06-13
Comunicado de la FDA sobre la seguridad de los medicamentos: FDA aprueba cambios en la etiqueta para el medicamento anticonvulsivo Potiga (ezogabina) que describen el riesgo de anormalidades en la retina, pérdida potencial de la visión y decoloración de la piel11-05-13
Comunicado de la FDA sobre la seguridad de los medicamentos: FDA pide al fabricante del medicamento Iclusig (ponatinib) para la leucemia que suspenda mercadeo y venta11-01-13
FDA Drug Safety Communication: FDA approves label changes for anti-seizure drug Potiga (ezogabine) describing risk of retinal abnormalities, potential vision loss, and skin discoloration10-31-13
FDA Drug Safety Communication: FDA asks manufacturer of the leukemia drug Iclusig (ponatinib) to suspend marketing and sales10-31-13
FDA Drug Safety Communication: FDA investigating leukemia drug Iclusig (ponatinib) after increased reports of serious blood clots in arteries and veins10-11-13
Comunicado de la FDA sobre la seguridad de los medicamentos: Recuadro con advertencia y nuevas recomendaciones para disminuir el riesgo de reactivación de la hepatitis B con los medicamentos Arzerra (ofatumumab) y Rituxan (rituximab), que combaten el cáncer y suprimen el sistema inmunitario10-01-13
Comunicado de la FDA sobre la seguridad de los medicamentos: La FDA advierte del aumento del riesgo de muerte con antibiótico Tygacil intravenoso (tigeciclina) y aprueba nuevo Recuadro con advertencia09-30-13
FDA Drug Safety Communication: FDA warns of increased risk of death with IV antibacterial Tygacil (tigecycline) and approves new Boxed Warning09-27-13
Comunicado de la FDA sobre la seguridad de los medicamentos: FDA requiere cambio de color de parches analgésicos Duragesic (fentanilo) para mayor seguridad y enfatiza que la exposición accidental a parches usados puede causar la muerte09-25-13
FDA Drug Safety Communication: Boxed Warning and new recommendations to decrease risk of hepatitis B reactivation with the immune-suppressing and anti-cancer drugs Arzerra (ofatumumab) and Rituxan (rituximab)09-25-13
FDA Drug Safety Communication: FDA requiring color changes to Duragesic (fentanyl) pain patches to aid safety―emphasizing that accidental exposure to used patches can cause death09-23-13
FDA investiga infección cerebral poco común en paciente que tomó Gilenya (fingolimod)09-03-13
FDA Drug Safety Communication: FDA investigating rare brain infection in patient taking Gilenya (fingolimod)08-29-13
Warning on Stolen Albuterol Sulfate Inhalation Solution and Ipratropium Bromide Inhalation Solution08-22-13
Update to FDA Alert About Stolen Insulin08-22-13
FDA Advisory About Levemir Insulin08-22-13
Comunicado de la FDA sobre la seguridad de los medicamentos: FDA requiere cambios en la etiqueta para advertir acerca del riesgo de daño neurológico potencialmente permanente por el uso de antibióticos con fluoroquinolona inyectados o de uso oral08-22-13
CDER Statement: FDA alerts pharmacies to concerns with testing conducted by Front Range Laboratories08-22-13
FDA Drug Safety Communication: FDA requires label changes to warn of risk for possibly permanent nerve damage from antibacterial fluoroquinolone drugs taken by mouth or by injection08-15-13
Drug Safety Oversight Board Meeting, March 18, 201008-15-13
Comunicado de la FDA sobre la seguridad de los medicamentos: FDA advierte que el medicamento antipirético y analgésico acetaminofén (paracetamol) puede causar reacciones poco comunes pero serias en la piel08-08-13
FDA Drug Safety Communication: FDA warns of rare but serious skin reactions with the pain reliever/fever reducer acetaminophen08-01-13
Comunicado de la FDA sobre la seguridad de los medicamentos: FDA limita el uso de tabletas orales de Nizoral (ketoconazol) debido a lesiones potencialmente fatales al hígado y riesgo de interacción con medicamentos y problemas de las glándulas suprarrenales07-31-13
FDA Drug Safety Communication: FDA approves label changes for antimalarial drug mefloquine hydrochloride due to risk of serious psychiatric and nerve side effects07-24-13
FDA Drug Safety Communication: FDA limits usage of Nizoral (ketoconazole) oral tablets due to potentially fatal liver injury and risk of drug interactions and adrenal gland problems07-26-13
June 2013: Additions and Deletions to the Drug Product List (PDF)07-15-13
FDA Drug Safety Communication: FDA approves label changes to include intestinal problems (sprue-like enteropathy) linked to blood pressure medicine olmesartan medoxomil07-03-13
FDA Adverse Event Reporting System (FAERS) Statistics06-11-13
FDA Drug Safety Communication: FDA is investigating two deaths following injection of long-acting antipsychotic Zyprexa Relprevv (olanzapine pamoate)06-18-13
May 2013: Additions and Deletions to the Drug Product List06-17-13
Update on Main Street Family Pharmacy Products: Samples of injectable methylprednisolone acetate test positive for microbial contamination06-07-13
CDERLearn06-03-13
FDA Drug Safety Communication: FDA approves label changes for zolpidem products, including new dosing and a recommendation to avoid driving the day after Ambien CR use05-17-13
FDA Drug Safety Communication: Valproate Anti-seizure Products Contraindicated for Migraine Prevention in Pregnant Women due to Decreased IQ Scores in Exposed Children05-06-13
Drug Safety Communication: FDA warns about potential medication errors resulting from confusion regarding nonproprietary name for breast cancer drug Kadcyla (ado-trastuzumab emtansine)05-03-13
FAERS Quarterly Data Files Documentation05-03-13
FDA Drug Safety Communication: FDA limits duration and usage of Samsca (tolvaptan) due to possible liver injury leading to organ transplant or death04-30-13
Funding and Support04-22-13
Small Business Education Series04-09-13
FDA Drug Safety Communication: FDA investigating reports of possible increased risk of pancreatitis and pre-cancerous findings of the pancreas from incretin mimetic drugs for type 2 diabetes03-13-13
FDA Drug Safety Communication: Azithromycin (Zithromax or Zmax) and the risk of potentially fatal heart rhythms03-12-13
FDA Drug Safety Communication: FDA suspends pediatric clinical trials of Sensipar (cinacalcet hydrochloride) after report of death02-26-13
FDA Drug Safety Communication: Safety review update of codeine use in children; new Boxed Warning and Contraindication on use after tonsillectomy and/or adenoidectomy02-20-13
Orange Book FR Safety or Effectiveness Determinations List (PDF)02-13-13
Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS) between July ? September 201202-11-13
Acetaminophen Toxicity01-31-13
NDC Database File (Zip Format)01-14-13
Comunicado de la FDA sobre la seguridad de los medicamentos: Riesgo de aletargamiento o menor nivel de alerta mental la mañana posterior al uso de medicamentos contra el insomnio; la FDA requiere reducir la dosis recomendada para ciertos medicamentos que contienen zolpidem01-10-13
FDA Drug Safety Communication: Risk of next-morning impairment after use of insomnia drugs; FDA requires lower recommended doses for certain drugs containing zolpidem (Ambien, Ambien CR, Edluar, and Zolpimist)01-10-13
Comunicado de la FDA sobre la seguridad de los medicamentos: Pradaxa (dabigatrán etexilato mesilato) no se debe usar en pacientes con válvulas protésicas del corazón12-26-12
Comunicado de la FDA sobre la seguridad de los medicamentos: Severas reacciones cutáneas después de tratamiento combinado con los medicamentos Incivek (telaprevir), peginterferón alfa y ribavirina para la hepatitis C12-21-12
Comunicado de la FDA sobre la seguridad de los medicamentos: Advertencia sobre el uso de Xyrem (oxibato de sodio) con bebidas alcohólicas o medicamentos ya que puede causar depresión respiratoria12-20-12
FDA Drug Safety Communication: Pradaxa (dabigatran etexilate mesylate) should not be used in patients with mechanical prosthetic heart valves12-19-12
FDA Drug Safety Communication: Serious skin reactions after combination treatment with the Hepatitis C drugs Incivek (telaprevir), peginterferon alfa, and ribavirin12-19-12
FDA Drug Safety Communication: Warning against use of Xyrem (sodium oxybate) with alcohol or drugs causing respiratory depression12-17-12
Comunicado de la FDA sobre la seguridad de los medicamentos: Actualización del estudio de seguridad sobre Chantix (vareniclina) y el riesgo de sucesos cardiovasculares adversos12-13-12
Comunicado de la FDA sobre la seguridad de los medicamentos: Cambio importante en la etiqueta del envase de heparina para indicar claramente la potencia total del medicamento12-12-12
FDA Drug Safety Communication: Safety review update of Chantix (varenicline) and risk of cardiovascular adverse events12-12-12
Comunicado de la FDA sobre la seguridad de los medicamentos: Información actualizada sobre la dosis intravenosa de 32 mg de ondansetrón (Zofran) y productos previamente mezclados de ondansetrón12-06-12
FDA Drug Safety Communication: Important change to heparin container labels to clearly state the total drug strength12-06-12
FDA Drug Safety Communication: Updated information on 32 mg intravenous ondansetron (Zofran) dose and pre-mixed ondansetron products12-04-12
Drug Establishments Current Registration Site11-29-12
FDA Drug Safety Communication: Update on the risk for serious bleeding events with the anticoagulant Pradaxa (dabigatran)11-27-12
BMIS Zip Download File11-26-12
Multistate outbreak of fungal meningitis and other infections11-20-12
FDA Drug Info Rounds11-14-12
Pediatric Exclusivity Statistics11-09-12
Additions/Deletions for Prescription and OTC Drug Product Lists11-16-12
Medication Guides11-16-12
Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies Conducted under Section 505A and 505B of the Federal Food, Drug, and Cosmetic Act, as amended by the FDA Amendments Act of 2012 (FDASIA)11-16-12
FDA Drug Safety Communication: Revised recommendations for Celexa (citalopram hydrobromide) related to a potential risk of abnormal heart rhythms with high doses11-23-12
Newly Added Guidance Documents11-21-12
Multistate outbreak of fungal meningitis and other infections11-20-12
Orange Book Zip File11-16-12
National Drug Code Directory11-26-12
BMIS Zip Download File11-26-12
FDA Drug Safety Communication: Updated information about the risk of blood clots in women taking birth control pills containing drospirenone11-23-12
FDA Drug Safety Communication: Safety review update of cancer drug Revlimid (lenalidomide) and risk of developing new types of malignancies11-23-12
Drugs@FDA Data Files11-28-12
FDA Drug Safety Communication: Update on the risk for serious bleeding events with the anticoagulant Pradaxa (dabigatran)11-27-12
FDA Drug Safety Communication: FDA recommends against use of Revatio (sildenafil) in children with pulmonary hypertension11-27-12
Truthful Prescription Drug Advertising and Promotion11-27-12
Drug Establishments Current Registration Site11-29-12
Drug Establishment Annual Registration Status Download File11-29-12
New and Generic Drug Approvals11-29-12
Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies Conducted under Section 505A and 505B of the Federal Food, Drug, and Cosmetic Act, as amended by the FDA Amendments Act of 2012 (FDASIA)11-16-12
FDA Drug Info Rounds11-14-12
Pediatric Exclusivity Statistics11-09-12
Newly Added Guidance Documents11-21-12
Multistate outbreak of fungal meningitis and other infections11-20-12
Orange Book Zip File11-16-12
Additions/Deletions for Prescription and OTC Drug Product Lists11-16-12
Medication Guides11-16-12
BMIS Zip Download File11-26-12
FDA Drug Safety Communication: Updated information about the risk of blood clots in women taking birth control pills containing drospirenone11-23-12
FDA Drug Safety Communication: Safety review update of cancer drug Revlimid (lenalidomide) and risk of developing new types of malignancies11-23-12
FDA Drug Safety Communication: Revised recommendations for Celexa (citalopram hydrobromide) related to a potential risk of abnormal heart rhythms with high doses11-23-12
Drugs@FDA Data Files11-28-12
FDA Drug Safety Communication: Update on the risk for serious bleeding events with the anticoagulant Pradaxa (dabigatran)11-27-12
FDA Drug Safety Communication: FDA recommends against use of Revatio (sildenafil) in children with pulmonary hypertension11-27-12
Truthful Prescription Drug Advertising and Promotion11-27-12
National Drug Code Directory11-26-12
Drug Establishments Current Registration Site11-29-12
Drug Establishment Annual Registration Status Download File11-29-12
New and Generic Drug Approvals11-29-12
Comunicado de la FDA sobre la seguridad de los medicamentos: Estudio de seguridad en curso sobre el medicamento Mirapex (pramipexole) para la enfermedad de Parkinson y el posible riesgo de insuficiencia cardíaca09-25-12
Comunicado de la FDA sobre la seguridad de los medicamentos: Estudio de seguridad en curso sobre el medicamento Mirapex (pramipexole) para la enfermedad de Parkinson y el posible riesgo de insuficiencia cardíaca09-25-12
FDA Drug Safety Communication: Ongoing safety review of Parkinson’s drug Mirapex (pramipexole) and possible risk of heart failure09-18-12
FDA Drug Safety Communication: Ongoing safety review of Parkinson's drug Mirapex (pramipexole) and possible risk of heart failure09-18-12
Comunicado de la FDA sobre la seguridad de los medicamentos: Casos poco comunes de quemaduras graves con el uso de analgésicos tópicos de venta libre para el dolor muscular y articular09-13-12
Comunicado de la FDA sobre la seguridad de los medicamentos: Casos poco comunes de quemaduras graves con el uso de analgésicos tópicos de venta libre para el dolor muscular y articular09-13-12
FDA Drug Safety Communication: Rare cases of serious burns with the use of over-the-counter topical muscle and joint pain relievers09-13-12
Comunicado de la FDA sobre la seguridad de los medicamentos La FDA recomienda que no se use Revatio en niños con hipertensión pulmonar09-05-12
Comunicado de la FDA sobre la seguridad de los medicamentos La FDA recomienda que no se use Revatio en niños con hipertensión pulmonar09-05-12
FDA Drug Safety Communication: FDA recommends against use of Revatio in children with pulmonary hypertension08-30-12
Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies Conducted under Section 505A and 505B of the Federal Food, Drug, and Cosmetic Act, as amended by the FDA Amendments Act of 2012 (FDASIA)08-28-12
Comunicado de la FDA sobre la seguridad de los medicamentos: El uso de codeína en ciertos niños tras amigdalectomía y/o adenoidectomía puede llevar a eventos adversos poco comunes pero que pueden poner en peligro la vida o causar la muerte08-22-12
Comunicado de la FDA sobre la seguridad de los medicamentos: El uso de codeína en ciertos niños tras amigdalectomía y/o adenoidectomía puede llevar a eventos adversos poco comunes pero que pueden poner en peligro la vida o causar la muerte08-22-12
FDA Drug Safety Communication: Codeine use in certain children after tonsillectomy and/or adenoidectomy may lead to rare, but life-threatening adverse events or death08-15-12
Comunicado de la FDA sobre la seguridad de los medicamentos: Riesgo de convulsiones en pacientes con esclerosis múltiple que toman Ampyra (dalfampridine)07-27-12
Comunicado de la FDA sobre la seguridad de los medicamentos: Riesgo de convulsiones en pacientes con esclerosis múltiple que toman Ampyra (dalfampridine)07-27-12
FDA Drug Safety Communication: Seizure risk for multiple sclerosis patients who take Ampyra (dalfampridine)07-23-12
Comunicado de la FDA sobre la seguridad de los medicamentos: Nueva información sobre la prolongación del intervalo QT con ondansetrón (Zofran)07-12-12
Comunicado de la FDA sobre la seguridad de los medicamentos: Nueva información sobre la prolongación del intervalo QT con ondansetrón (Zofran)07-12-12
FDA Drug Safety Communication: New information regarding QT prolongation with ondansetron (Zofran)06-29-12
FDA Drug Safety Communication: Cefepime and risk of seizure in patients not receiving dosage adjustments for kidney impairment06-26-12
Comunicado de la FDA sobre la seguridad de los medicamentos: Recomendaciones modificadas para observación cardiovascular y uso del medicamento Gilenya (fingolimod) para la esclerosis múltiple05-21-12
Comunicado de la FDA sobre la seguridad de los medicamentos: Recomendaciones modificadas para observación cardiovascular y uso del medicamento Gilenya (fingolimod) para la esclerosis múltiple05-21-12
Comunicado de la FDA sobre la seguridad de los medicamentos: Informe actualizado sobre la seguridad del medicamento Revlimid (lenalidomida) para el cáncer y el riesgo de nuevos tipos de neoplasias (nuevos tipos de cáncer)05-17-12
Comunicado de la FDA sobre la seguridad de los medicamentos: Informe actualizado sobre la seguridad del medicamento Revlimid (lenalidomida) para el cáncer y el riesgo de nuevos tipos de neoplasias (nuevos tipos de cáncer)05-17-12
FDA Drug Safety Communication: Revised recommendations for cardiovascular monitoring and use of multiple sclerosis drug Gilenya (fingolimod)05-14-12
FDA Drug Safety Communication: Safety review update of cancer drug Revlimid (lenalidomide) and risk of developing new types of malignancies05-07-12
Comunicado de la FDA sobre la seguridad de los medicamentos: Información actualizada sobre la interacción entre el medicamento Victrelis (boceprevir) y ciertos medicamentos reforzados inhibidores de la proteasa del VIH05-07-12
Comunicado de la FDA sobre la seguridad de los medicamentos: Información actualizada sobre la interacción entre el medicamento Victrelis (boceprevir) y ciertos medicamentos reforzados inhibidores de la proteasa del VIH05-07-12
Comunicado de la FDA sobre la seguridad de los medicamentos: Nueva advertencia y contraindicación sobre medicamentos para la presión arterial que contienen aliskiren05-01-12
Comunicado de la FDA sobre la seguridad de los medicamentos: Nueva advertencia y contraindicación sobre medicamentos para la presión arterial que contienen aliskiren05-01-12
Webinar: Practical Advice for Preventing Surgical Fires--Safety Strategies from the Front Lines04-26-12
FDA Drug Safety Communication: Updated information on drug interactions between Victrelis (boceprevir) and certain boosted HIV protease inhibitor drugs04-26-12
Comunicado de la FDA sobre la seguridad de los medicamentos: Información actualizada sobre el riesgo de coágulos de sangre en las mujeres que toman pastillas anticonceptivas que contienen drospirenona04-20-12
Comunicado de la FDA sobre la seguridad de los medicamentos: Información actualizada sobre el riesgo de coágulos de sangre en las mujeres que toman pastillas anticonceptivas que contienen drospirenona04-20-12
FDA Drug Safety Communication: New Warning and Contraindication for blood pressure medicines containing aliskiren (Tekturna)04-20-12
FDA Drug Safety Communication: Updated information about the risk of blood clots in women taking birth control pills containing drospirenone04-10-12
Comunicado de la FDA sobre la seguridad de los medicamentos: Recomendaciones modificadas para Celexa (citalopram bromhidrato) relacionadas con el riesgo potencial de ritmo cardiaco anormal con dosis altas04-05-12
Comunicado de la FDA sobre la seguridad de los medicamentos: La interacción entre ciertos medicamentos para el VIH o hepatitis C y los medicamentos con estatinas para reducir el colesterol, puede aumentar el riesgo de lesiones musculares04-05-12
Comunicado de la FDA sobre la seguridad de los medicamentos: La interacción entre ciertos medicamentos para el VIH o hepatitis C y los medicamentos con estatinas para reducir el colesterol, puede aumentar el riesgo de lesiones musculares04-05-12
FDA Drug Safety Communication: Revised recommendations for Celexa (citalopram hydrobromide) related to a potential risk of abnormal heart rhythms with high doses03-28-12
Postmarketing Requirements and Commitments: Reports03-13-12
Comunicado de la FDA sobre la seguridad de los medicamentos: La interacción entre ciertos medicamentos para el VIH o hepatitis C y los medicamentos con estatinas para reducir el colesterol, puede aumentar el riesgo de lesiones musculares03-12-12
Comunicado de la FDA sobre la seguridad de los medicamentos: La interacción entre ciertos medicamentos para el VIH o hepatitis C y los medicamentos con estatinas para reducir el colesterol, puede aumentar el riesgo de lesiones musculares03-12-12
Comunicado de la FDA sobre la seguridad de los medicamentos: Cambios importantes en la etiqueta de seguridad de los medicamentos para reducir el colesterol conocidos como estatinas03-05-12
FDA Drug Safety Communication: Interactions between certain HIV or hepatitis C drugs and cholesterol-lowering statin drugs can increase the risk of muscle injury03-01-12
FDA Drug Safety Communication: Important safety label changes to cholesterol-lowering statin drugs02-28-12
CDER World02-24-12
Comunicado de la FDA sobre la seguridad de los medicamentos: Reingreso planeado al mercado de CardioGen-82 con nuevo recuadro de advertencia02-23-12
Comunicado de la FDA sobre la seguridad de los medicamentos: Importantes interacciones entre el medicamento Victrelis (boceprevir) y los medicamentos inhibidores de la proteasa del virus de inmunodeficiencia humana (VIH) reforzados con ritonavir02-22-12
Comunicado de la FDA sobre la seguridad de los medicamentos: La diarrea asociada con Clostridum difficile puede estar relacionada con los medicamentos contra la acidez estomacal denominados inhibidores de la bomba de protones (PPIs por sus siglas en inglés)02-21-12
Comunicado de la FDA sobre la seguridad de los medicamentos: La diarrea asociada con Clostridum difficile puede estar relacionada con los medicamentos contra la acidez estomacal denominados inhibidores de la bomba de protones (PPIs por sus siglas en inglés)02-21-12
FDA Drug Safety Communication: Planned return of CardioGen-82 to market with new Boxed Warning02-15-12
Comunicado de la FDA sobre la seguridad de los medicamentos: Nuevo factor de riesgo para la leucoencefalopatía multifocal progresiva (PML por sus siglas en inglés) relacionado con Tysabri (natalizumab)02-10-12
Comunicado de la FDA sobre la seguridad de los medicamentos: Nuevo factor de riesgo para la leucoencefalopatía multifocal progresiva (PML por sus siglas en inglés) relacionado con Tysabri (natalizumab)02-10-12
FDA Drug Safety Communication: Important drug interactions between Victrelis (boceprevir) and ritonavir-boosted human immunodeficiency virus (HIV) protease inhibitor drugs02-09-12
FDA Drug Safety Communication: Clostridium difficile-associated diarrhea can be associated with stomach acid drugs known as proton pump inhibitors (PPIs)02-08-12
Prescription to Over-the-Counter (OTC) Switch List02-08-12
Resources and Tools for Preventing Surgical Fires02-06-12
Initiative Partners02-03-12
FDA Drug Safety Communication: New risk factor for Progressive Multifocal Leukoencephalopathy (PML) associated with Tysabri (natalizumab)01-20-12
Medication Guides01-17-12
FDA Drug Safety Communication: New Boxed Warning and Contraindication for Adcetris (brentuximab vedotin)01-13-12
FDA Drug Safety Communication: Update: Preliminary findings from ongoing investigations of CardioGen-8201-12-12
FDA Statement on recently terminated clinical trial with Doribax (doripenem)01-06-12
Questions and Answers: FDA approves a class Risk Evaluation and Mitigation Strategy (REMS) for transmucosal immediate-release fentanyl (TIRF) medicines12-29-11
FDA Alerts Pharmacists and Health Care Professionals to Potential for Injury when Dispensing the Similar-Sounding Drugs Durezol and Durasal12-28-11
FDA Drug Safety Communication: Addition of another concentration of liquid acetaminophen marketed for infants12-22-11
FDA Drug Safety Communication: Safety review of a reported death after the first dose of Multiple Sclerosis drug Gilenya (fingolimod)12-20-11
FDA Drug Safety Communication: Review update of Multaq (dronedarone) and increased risk of death and serious cardiovascular adverse events12-19-11
FDA Drug Safety Communication: Revised dose limitation for Zocor (simvastatin) when taken with amiodarone12-15-11
FDA Drug Safety Communication: Selective serotonin reuptake inhibitor (SSRI) antidepressant use during pregnancy and reports of a rare heart and lung condition in newborn babies12-14-11
FDA Drug Safety Communication: Safety Review Update of Medications used to treat Attention-Deficit/Hyperactivity Disorder (ADHD) in adults12-12-11
FDA Drug Safety Communication: Safety review of post-market reports of serious bleeding events with the anticoagulant Pradaxa (dabigatran etexilate mesylate)12-07-11
FDA Drug Safety Communication: Modified Risk Evaluation and Mitigation Strategies (REMS) for Nplate (romiplostim) and Promacta (eltrombopag)12-06-11
FDA Drug Safety Communication: Reminder to healthcare providers and patients to enroll in the Avandia-Rosiglitazone Medicines Access Program11-04-11
FDA Drug Safety Communication: UPDATE on Tumor Necrosis Factor (TNF) blockers and risk for pediatric malignancy11-03-11
FDA Drug Safety Communication: Safety Review Update of Medications used to treat Attention-Deficit/Hyperactivity Disorder (ADHD) in children and young adults11-01-11
Opportunities for Collaboration10-28-11
FDA Drug Safety Communication: Updated information about the FDA-funded study on risk of blood clots in women taking birth control pills containing drospirenone10-27-11
Comunicado de la FDA sobre la seguridad de los medicamentos: Reacciones graves en el sistema nervioso central (SNC) cuando se administra linezolid (Zyvox) a pacientes que toman ciertos medicamentos psiquiátricos10-26-11
FDA Drug Safety Communication: Safety review update of Chantix (varenicline) and risk of neuropsychiatric adverse events10-24-11
FDA Drug Safety Communication: Updated information about the drug interaction between linezolid (Zyvox) and serotonergic psychiatric medications10-20-11
FDA Drug Safety Communication: Updated information about the drug interaction between methylene blue (methylthioninium chloride) and serotonergic psychiatric medications10-20-11
Comunicado de la FDA sobre la seguridad de los medicamentos: Continúa la revisión sobre la seguridad de los medicamentos para la osteoporosis (bifosfonatos) por vía oral en relación con un probable aumento de riesgo de cáncer de esófago10-13-11
Comunicado de la FDA sobre la seguridad de los medicamentos: La etiqueta del medicamento Chantix (vareniclina) ahora contiene información actualizada sobre su eficacia y seguridad10-13-11
Comunicado de la FDA sobre la seguridad de los medicamentos: Posibles reacciones graves en el SNC cuando se administra azul de metileno a pacientes que toman ciertos medicamentos psiquiátricos.10-13-11
Comunicado de la FDA sobre la seguridad de los medicamentos: Actualización de las etiquetas de los medicamentos que contienen pioglitazona10-13-11
Comunicado de la FDA sobre la seguridad de los medicamentos: Actualización de la revisión de seguridad de la hormona de crecimiento humana recombinante (somatropina) y su posible aumento de riesgo de muerte10-13-11
Comunicado de la FDA sobre la seguridad de los medicamentos: Ritmos cardíacos anormales asociados con dosis altas de Celexa (bromhidrato de citalopram)10-13-11
Preventing Surgical Fires10-13-11
Comunicado de la FDA sobre la seguridad de los medicamentos: Informes sobre un efecto adverso raro pero grave y potencialmente fatal del uso de benzocaína en gel o líquido de venta libre que se aplica a las encías o la boca10-13-11
FDA Drug Safety Communication: Sprycel (dasatinib) and risk of pulmonary arterial hypertension10-11-11
Questions and Answers - Safety review update on the possible increased risk of blood clots with birth control pills containing drospirenone09-26-11
FDA Drug Safety Communication: Safety review update on the possible increased risk of blood clots with birth control pills containing drospirenone09-26-11
Stay Informed about Small Business09-20-11
Comunicado de Seguridad de Medicamentos de la FDA: Ritmos cardíacos anormales asociados con dosis altas de Celexa (bromhidrato de citalopram)09-12-11
Statement from FDA Commissioner Margaret Hamburg, M.D. and Assistant Secretary for Health Howard Koh, M.D., M.P.H. on Drug Shortages09-09-11
FDA Drug Safety Communication: Drug labels for the Tumor Necrosis Factor-alpha (TNFα) blockers now include warnings about infection with Legionella and Listeria bacteria09-07-11
FDA Drug Safety Communication: Abnormal heart rhythms associated with high doses of Celexa (citalopram hydrobromide)08-25-11
Comunicado de Seguridad de Medicamentos de la FDA: Informes sobre un efecto adverso raro pero grave y potencialmente fatal del uso de benzocaína en gel o líquido de venta libre que se aplica a las encías o la boca08-23-11
FDA Alerts Health Care Professionals of Infection Risk from Repackaged Avastin Intravitreal Injections08-30-11
FDA Drug Safety Communication: Serious allergic reactions reported with the use of Saphris (asenapine maleate)09-01-11
FDA Drug Safety Communication: New contraindication and updated warning on kidney impairment for Reclast (zoledronic acid)09-02-11
Comunicado de Seguridad de Medicamentos de la FDA: Actualización de la revisión de seguridad de la hormona de crecimiento humana recombinante (somatropina) y su posible aumento de riesgo de muerte08-17-11
Comunicado de Seguridad de Medicamentos de la FDA: Actualización de las etiquetas de los medicamentos que contienen pioglitazona08-17-11
Comunicado de Seguridad de Medicamentos de la FDA: Actualización de la revisión de seguridad de la hormona de crecimiento humana recombinante (somatropina) y su posible aumento de riesgo de muerte08-17-11
Comunicado de Seguridad de Medicamentos de la FDA: Actualización de las etiquetas de los medicamentos que contienen pioglitazona08-17-11
Drug Establishment Annual Registration Status Download File08-15-11
Comunicado de Seguridad de Medicamentos de la FDA: Reacciones graves en el sistema nervioso central (SNC) cuando se administra linezolid (Zyvox) a pacientes que toman ciertos medicamentos psiquiátricos08-12-11
FDA Drug Safety Communication: Serious CNS reactions possible when linezolid (Zyvox) is given to patients taking certain psychiatric medications08-12-11
Comunicado de Seguridad de Medicamentos de la FDA: Posibles reacciones graves en el SNC cuando se administra azul de metileno a pacientes que toman ciertos medicamentos psiquiátricos.08-12-11
Comunicado de seguridad de medicamentos de la FDA: La etiqueta del medicamento Chantix (vareniclina) ahora contiene información actualizada de eficacia y seguridad08-05-11
FDA Drug Safety Communication: Updated drug labels for pioglitazone-containing medicines08-04-11
FDA Drug Safety Communication: Safety review update of Recombinant Human Growth Hormone (somatropin) and possible increased risk of death08-04-11
FDA Drug Safety Communication:Use of long-term, high-dose Diflucan (fluconazole) during pregnancy may be associated with birth defects in infants08-03-11
Comunicado de seguridad de medicamentos de la FDA: Continúa la revisión de seguridad de los medicamentos por vía oral para la osteoporosis (bifosfonatos) en relación con un probable mayor riesgo de cáncer de esófago08-02-11
FDA Drug Safety Communication: Serious CNS reactions possible when methylene blue is given to patients taking certain psychiatric medications07-26-11
FDA Drug Safety Communication: Serious CNS reactions possible when linezolid (Zyvox®) is given to patients taking certain psychiatric medications07-26-11
FDA Drug Safety Communication: FDA alerts healthcare professionals to stop performing heart scans with CardioGen-82 due to potential for increased radiation exposure in patients07-26-11
FDA Drug Safety Communication: Chantix (varenicline) drug label now contains updated efficacy and safety information07-25-11
FDA Drug Safety Communication: Multaq (dronedarone) and increased risk of death and serious cardiovascular adverse events07-21-11
FDA Drug Safety Communication: Ongoing safety review of oral osteoporosis drugs (bisphosphonates) and potential increased risk of esophageal cancer07-21-11
FDA Drug Safety Communication: Increased radiation exposure due to undetected strontium breakthrough when using CardioGen-82 for cardiac positron emission tomography (PET) scans07-15-11
FDA Drug Safety Communication: Children born to mothers who took Valproate products while pregnant may have impaired cognitive development06-30-11
Drug Firm Annual Registration Status Download File06-29-11
FDA Drug Safety Communication: Modified dosing recommendations to improve the safe use of Erythropoiesis-Stimulating Agents (ESAs) in chronic kidney disease06-24-11
FDA Drug Safety Communication: Chantix (varenicline) may increase the risk of certain cardiovascular adverse events in patients with cardiovascular disease06-16-11
FDA Drug Safety Communication: Update to ongoing safety review of Actos (pioglitazone) and increased risk of bladder cancer06-15-11
Questions and Answers: FDA announces new requirements for over-the-counter (OTC) sunscreen products marketed in the U.S.06-14-11
Sunscreen06-14-11
FDA Drug Safety Communication: Medication errors resulting from confusion between risperidone (Risperdal) and ropinirole (Requip)06-13-11
Questions and Answers: 5-alpha reductase inhibitors (5-ARIs) may increase the risk of a more serious form of prostate cancer06-09-11
FDA Drug Safety Communication: 5-alpha reductase inhibitors (5-ARIs) may increase the risk of a more serious form of prostate cancer06-09-11
FDA Drug Safety Communication: New restrictions, contraindications, and dose limitations for Zocor (simvastatin) to reduce the risk of muscle injury06-08-11
FDA Drug Safety Communication: No increase in risk of cancer with certain blood pressure drugs--Angiotensin Receptor Blockers (ARBs)06-01-11
Questions and Answers – Ongoing safety review of birth control pills containing drospirenone and a possible increased risk of blood clots05-31-11
FDA Drug Safety Communication: Safety Review of possible increased risk of blood clots with birth control pills containing drospirenone05-31-11
Questions and Answers ? Ongoing safety review of birth control pills containing drospirenone and a possible increased risk of blood clots05-31-11
FDA Statement on the AIM-HIGH Trial05-26-11
Chantix: Quarterwatch Article05-19-11
FDA Drug Safety Communication: Updated Risk Evaluation and Mitigation Strategy (REMS) to Restrict Access to Rosiglitazone-containing Medicines including Avandia, Avandamet, and Avandaryl05-18-11
Postmarketing Drug Safety Evaluations05-13-11
FDA Drug Safety Communication: Connection problems involving certain needleless pre-filled glass syringes containing adenosine and amiodarone05-06-11
Questions and Answers on Guidance for Industry: Dosage Delivery Devices for Orally Ingested OTC Liquid Drug Products05-04-11
Natural Disaster Response04-28-11
FDA Drug Safety Communication: Safety update on Progressive Multifocal Leukoencephalopathy (PML) associated with Tysabri (natalizumab)04-22-11
FDA Drug Safety Communication: FDA requires post-market safety trials for Long-Acting Beta-Agonists (LABAs)04-14-11
FDA Drug Safety Communication: Safety Review update on reports of Hepatosplenic T-Cell Lymphoma in adolescents and young adults receiving tumor necrosis factor (TNF) blockers, azathioprine and/or mercaptopurine04-14-11
FDA Drug Safety Communication: Safety Review Update of Benicar (olmesartan) and cardiovascular events04-13-11
FDA Drug Safety Communication: Ongoing safety review of Revlimid (lenalidomide) and possible increased risk of developing new malignancies04-08-11
FDA Drug Safety Communication: FDA continues to receive reports of a rare, but serious and potentially fatal adverse effect with the use of benzocaine sprays for medical procedures04-07-11
FDA Drug Safety Communication: Reports of a rare, but serious and potentially fatal adverse effect with the use of over-the-counter (OTC) benzocaine gels and liquids applied to the gums or mouth04-07-11
FDA Drug Safety Communication: Special storage and handling requirements must be followed for Pradaxa (dabigatran etexilate mesylate) capsules03-29-11
FDA Drug Safety Communication: Serious health problems seen in premature babies given Kaletra (lopinavir/ritonavir) oral solution03-08-11
FDA Drug Safety Communication: Liver injury warning to be removed from Letairis (ambrisentan) tablets03-04-11
FDA Drug Safety Communication: Risk of oral clefts in children born to mothers taking Topamax (topiramate)03-04-11
FDA Drug Safety Communication: Safety Review update of Abacavir and possible increased risk of heart attack03-02-11
FDA Drug Safety Communication: Low magnesium levels can be associated with long-term use of Proton Pump Inhibitor drugs (PPIs)03-02-11
FDA Drug Safety Communication: Antipsychotic drug labels updated on use during pregnancy and risk of abnormal muscle movements and withdrawal symptoms in newborns02-22-11
FDA Drug Safety Communication: New warnings against use of terbutaline to treat preterm labor02-17-11
FDA Drug Safety Communication: Avandia (rosiglitazone) labels now contain updated information about cardiovascular risks and use in certain patients02-03-11
Warning Letters 201101-24-11
FDA Drug Safety Communication: Severe liver injury associated with the use of dronedarone (marketed as Multaq)01-14-11
Acetaminophen Information01-13-11
FDA Drug Safety Communication: Update to ongoing safety review of Lantus (insulin glargine) and possible risk of cancer01-12-11
Safe Use Initiative: FDA-Sponsored Stakeholder Meeting on Surgical Fire Prevention01-11-11
Midodrine Update: Opening of a public docket01-11-11
FDA Drug Safety Communication: Ongoing safety review of Recombinant Human Growth Hormone (somatropin) and possible increased risk of death12-22-10
FDA Drug Safety Communication: Abnormal heart rhythms associated with use of Anzemet (dolasetron mesylate)12-17-10
FDA Drug Safety Communication: Death resulting from overdose after accidental ingestion of Tessalon (benzonatate) by children under 10 years of age12-14-10
FDA Drug Safety Communication: FDA recommends against the continued use of propoxyphene11-19-10
Safe Use Initiative: Expert Roundtable on Pain Management in Older Adults11-17-10
Final Report on the Postmarketing Requirement/Postmarketing Commitment Backlog Review (2nd Annual Report)11-10-10
FDA reminder to avoid concomitant use of Plavix (clopidogrel) and omeprazole10-27-10
Safe Use Initiative: Acetaminophen Toxicity10-25-10
Safe Use Initiative Fact Sheet10-25-10
Advisory to Drug and Dietary Supplement Manufacturers, Compounding Pharmacies and Distributors of Excipients and Dietary Ingredients ? FDA Detects High Levels of Peroxide in Crospovidone10-22-10
Advisory to Drug and Dietary Supplement Manufacturers, Compounding Pharmacies and Distributors of Excipients and Dietary Ingredients – FDA Detects High Levels of Peroxide in Crospovidone10-22-10
FDA Drug Safety Communication: Invirase (saquinavir) labels now contain updated risk information on abnormal heart rhythms10-19-10
FDA Drug Safety Communication: Update to Ongoing Safety Review of GnRH Agonists and Notification to Manufacturers of GnRH Agonists to Add New Safety Information to Labeling Regarding Increased Risk of Diabetes and Certain Cardiovascular Diseases10-19-10
Questions and Answers on Unapproved Chelation Products10-14-10
FDA Drug Safety Communication: Safety update for osteoporosis drugs, bisphosphonates, and atypical fractures10-14-10
FDA Drug Safety Communication: FDA Recommends Against the Continued Use of Meridia (sibutramine)10-08-10
Safe Use Initiative: Opportunities for Collaboration10-05-10
Safe Use Initiative09-20-10
FDA Drug Safety Communication: Ongoing Safety Review of Actos (pioglitazone) and Potential Increased Risk of Bladder Cancer After Two Years Exposure09-17-10
FDA Drug Safety Communication: New dosing recommendations to prevent potential Valcyte (valganciclovir) overdose in pediatric transplant patients09-15-10
FDA Statement on ASBMR report: Possible Increased Risk of Certain Types of Thigh Bone Fractures with Long-Term Bisphosphonates Use09-15-10
Adverse Events Reporting System (AERS) Electronic Submissions09-13-10
FDA Drug Safety Communication: New warnings for using gadolinium-based contrast agents in patients with kidney dysfunction09-09-10
Safe Drug Use After a Natural Disaster09-02-10
Information Regarding Insulin Storage and Switching Between Products in an Emergency09-02-10
FDA Drug Safety Communication: Increased risk of death with Tygacil (tigecycline) compared to other antibiotics used to treat similar infections09-01-10
September 20, 2010: Cardiovascular and Renal Drugs Advisory Committee Meeting Announcement08-27-10
FDA Drug Safety Communication: Ongoing Safety Review of Stalevo and possible increased cardiovascular risk08-20-10
FDA Drug Safety Communication: Aseptic meningitis associated with use of Lamictal (lamotrigine)08-10-10
FDA Drug Safety Communication: Serious medication errors from intravenous administration of nimodipine oral capsules08-02-10
FDA Drug Safety Communication: Ongoing safety review of Evamist (estradiol transdermal spray) and unintended exposure of children and pets to topical estrogen07-29-10
FDA Drug Safety Communication: Eosinophilic pneumonia associated with the use of Cubicin (daptomycin)07-29-10
FDA Statement on Avandia TIDE Trial07-21-10
FDA Drug Safety Communication: New boxed warning for severe liver injury with arthritis drug Arava (leflunomide)07-12-10
FDA Drug Safety Communication: New risk management plan and patient Medication Guide for Qualaquin (quinine sulfate)07-08-10
Peramivir Emergency Use Authorization Disposition Letter and Question and Answer Attachment06-22-10
Tamiflu and Relenza Emergency Use Authorization Disposition Letters and Question and Answer Attachments06-22-10
CDER Key Officials List06-22-10
Implementation of the Biologics Price Competition and Innovation Act of 200906-22-10
Termination of Declarations of Emergency Justifying Emergency Use Authorization (EUA) of Certain Antiviral Drugs—Zanamivir, Oseltamivir Phosphate, and Peramivir06-22-10
Termination of Declarations of Emergency Justifying Emergency Use Authorization (EUA) of Certain Antiviral Drugs?Zanamivir, Oseltamivir Phosphate, and Peramivir06-22-10
FDA Drug Safety Communication: Ongoing safety review of Benicar and cardiovascular events06-11-10
FDA Drug Safety Communication: Drug labels now contain updated recommendations on the appropriate use of long-acting inhaled asthma medications called Long-Acting Beta-Agonists (LABAs)06-02-10
FDA Public Health Alert: Healthcare Professionals Warned Not To Use Certain Intravenous Metronidazole, Ondansetron, and Ciprofloxacin Due To Potential Contamination05-31-10
FDA Public Health Alert: Healthcare Professionals Warned Not To Use Certain Intravenous Metronidazole, Ondansetron, and Ciprofloxacin Due To Contamination05-30-10
FDA Drug Safety Communication: Completed safety review of Xenical/Alli (orlistat) and severe liver injury05-26-10
FDA Drug Safety Communication: Possible increased risk of fractures of the hip, wrist, and spine with the use of proton pump inhibitors05-25-10
CDER Statement to Healthcare Professionals: Restricted Availability of Thyrogen05-24-10
Updated Questions and Answers for Healthcare Professionals and the Public: Use an Approved Pancreatic Enzyme Product (PEP)05-24-10
FDA Drug Info Rounds05-19-10
FDA Drug Safety Communication: Medication errors from swallowing topical Benadryl Extra Strength Itch Stopping Gel05-12-10
Truthful Prescription Drug Advertising and Promotion (Bad Ad Program)05-11-10
Dear Colleague Letter (Bad Ad Program)05-11-10
Key Points of FDA Healthcare Professional Outreach (Bad Ad Program)05-11-10
FDA Drug Safety Communication: Ongoing Safety Review of GnRH Agonists and possible increased risk of diabetes and certain cardiovascular diseases05-03-10
4th Annual FDA/DIA Statistics Forum: Integrating Knowledge in Clinical Development: Meta-analysis, Non-Inferiority, and Related Topics - The FDA/HHS Presentations04-22-10
FDA Drug Safety Communication: New Boxed Warning on severe liver injury with propylthiouracil04-21-10
Orange Book Zip File04-21-10
Disposal by Flushing of Certain Unused Medicines: What You Should Know04-14-10
Phase-Out of Epinephrine CFC Metered-Dose Inhalers04-14-10
Phase-Out of Albuterol CFC Metered-Dose Inhalers04-14-10
Phase-Out of CFC Metered-Dose Inhalers04-14-10
Phase-Out of CFC Metered-Dose Inhalers Containing flunisolide, triamcinolone, metaproterenol, pirbuterol, albuterol and ipratropium in combination, cromolyn, and nedocromil04-14-10
Questions and Answers for Healthcare Professionals and the Public: Use an Approved Pancreatic Enzyme Product (PEP)04-12-10
Written Request Template04-09-10
FDA Drug Safety Communication: Ongoing safety review of high-dose Zocor (simvastatin) and increased risk of muscle injury04-08-10
Positron Emission Tomography (PET): Additional Questions and Answers Based on December 9, 2009 Stakeholder Call04-08-10
FDA Drug Safety Communication: Update: Follow up to the Public Health Alert about Changes to the Heparin Sodium USP Monograph04-07-10
Question and Answers about Changes to the USP Heparin Monograph04-07-10
Information for Consumers: What You Should Know about Changes to Heparin04-07-10
FDA Public Health Alert: Change in Heparin USP Monograph04-06-10
OxyContin - Questions and Answers04-05-10
Annex 9: Tablet Friability General Chapter04-02-10
FDA Drug Safety Communication: Ongoing Safety Review of Stalevo (entacapone/carbidopa/levodopa) and possible development of Prostate Cancer03-31-10
Newly Added Guidance Documents03-26-10
Breakdown of FDAAA Completed Pediatric Studies03-24-10
February 2010: Additions and Deletions to the Drug Product List03-23-10
Pediatric Exclusivity Granted03-19-10
FDA Drug Safety Communication: Ongoing safety review of high-dose Zocor* (simvastatin) and increased risk of muscle injury03-19-10
Pharmacokinetics in Patients with Impaired Renal Function ? Study Design, Data Analysis, and Impact on Dosing and Labeling03-17-10
List of Determinations Including Written Request03-17-10
Pharmacokinetics in Patients with Impaired Renal Function — Study Design, Data Analysis, and Impact on Dosing and Labeling03-17-10
Suitability Petitions03-16-10
FDA Drug Safety Communication: Reduced effectiveness of Plavix (clopidogrel) in patients who are poor metabolizers of the drug03-12-10
FDA Drug Safety Communication: Ongoing safety review of oral bisphosphonates and atypical subtrochanteric femur fractures03-10-10
New and Generic Drug Approvals03-09-10
Non-Inferiority Clinical Trials02-26-10
Submission of Documentation in Applications for Parametric Release of Human and Veterinary Drug Products Terminally Sterilized by Moist Heat Processes02-25-10
FDA Drug Safety Communication: Ongoing safety review of Invirase (saquinavir) and possible association with abnormal heart rhythms02-23-10
FDA Drug Safety Communication: Ongoing review of Avandia (rosiglitazone) and cardiovascular safety02-22-10
Potential Signals of Serious Risks/New Safety Information Identified from the Adverse Event Reporting System (AERS) between July - September 200902-18-10
Potential Signals of Serious Risks/New Safety Information Identified from the Adverse Event Reporting System (AERS) between January - March 200802-18-10
Potential Signals of Serious Risks/New Safety Information Identified from the Adverse Event Reporting System (AERS) between April - June 200802-18-10
Potential Signals of Serious Risks/New Safety Information Identified from the Adverse Event Reporting System (AERS) between October - December 200802-18-10
Potential Signals of Serious Risks/New Safety Information Identified from the Adverse Event Reporting System (AERS) between January - March 200902-18-10
Potential Signals of Serious Risks/New Safety Information Identified from the Adverse Event Reporting System (AERS) between April - June 200902-18-10
Potential Signals of Serious Risks/New Safety Information Identified from the Adverse Event Reporting System (AERS)02-18-10
Orange Book FR Safety or Effectiveness Determinations List (PDF)02-18-10
FDA Drug Safety Communication: New safety requirements for long-acting inhaled asthma medications called Long-Acting Beta-Agonists (LABAs)02-18-10
FDA Drug Safety Communication: Product Confusion with Maalox Total Relief and Maalox Liquid Products02-18-10
Drug Safety Communication: Erythropoiesis-Stimulating Agents (ESAs): Procrit, Epogen and Aranesp02-16-10
BMIS Zip Download File02-11-10
Questions and Answers for Healthcare Professionals: CRESTOR and the JUPITER Trial02-08-10
FDA Drug Safety Communication: Risk of Progressive Multifocal Leukoencephalopathy (PML) with the use of Tysabri (natalizumab)02-05-10
Contents of a Complete Submission for the Evaluation of Proprietary Names02-05-10
First-Time Generics - December 200902-03-10
Drug Master Files (DMFs)02-02-10
FDA Technical Briefing on Its FY 2011 Budget Request01-29-10
FDA Drug Safety Communication: Serious liver disorder associated with the use of Videx/Videx EC (didanosine)01-29-10
Information for Healthcare Professionals: Ceftriaxone (marketed as Rocephin and generics)01-28-10
Information for Healthcare Professionals: Cefepime (marketed as Maxipime)01-26-10
The Use of Mechanical Calibration of Dissolution Apparatus 1 and 2 ? Current Good Manufacturing Practice (CGMP)01-26-10
Assessment of Abuse Potential of Drugs01-26-10
The Use of Mechanical Calibration of Dissolution Apparatus 1 and 2 – Current Good Manufacturing Practice (CGMP)01-26-10
UPDATED Public Health Alert: Counterfeit Alli containing sibutramine01-23-10
Follow-Up to the November 2009 Early Communication about an Ongoing Safety Review of Sibutramine, Marketed as Meridia01-22-10
The Adverse Event Reporting System (AERS): Latest Quarterly Data Files01-19-10
The Adverse Event Reporting System (AERS): Latest Quarterly Data Files01-19-10
FDA Informs Consumers of a Nationwide Voluntary Recall of Certain Tylenol Products01-15-10
Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book)01-15-10
Generic Drugs: Information for Industry01-15-10
Follow-Up to the October 2008 Updated Early Communication about an Ongoing Safety Review of Tiotropium (marketed as Spiriva HandiHaler)01-14-10
Inactive Ingredients Database Download01-13-10
Warning Letters 201001-12-10
Guidance to Pharmacies: Compounding Tamiflu Oral Suspension in Advance to Provide for Multiple Prescriptions01-11-10
Clinical Investigator Inspection List (CLIIL)01-08-10
Spectrum of Diseases/Conditions01-08-10
Planning for the Effects of High Absenteeism to Ensure Availability of Medically Necessary Drug Products01-07-10
Updated Information on Leukotriene Inhibitors: Montelukast (marketed as Singulair), Zafirlukast (marketed as Accolate), and Zileuton (marketed as Zyflo and Zyflo CR)01-05-10
Rulemaking History for General Procedures and Policies for OTC Drug Products12-31-09
Adverse Event Reporting System (AERS) Statistics12-31-09
Status of OTC Rulemakings12-29-09
Annex 5: Disintegration Test General Chapter12-22-09
Follow-Up to the August 2008 Early Communication About an Ongoing Safety Review of Ezetimibe/Simvastatin (marketed as Vytorin), Simvastatin (marketed as Zocor) and Ezetimibe (marketed as Zetia) - FDA Investigates a Report from the SEAS Trial12-22-09
Annex 8: Sterility Test General Chapter12-22-09
Additions/Deletions for Prescription and OTC Drug Product Lists12-18-09
Orange Book Current Cumulative Supplement12-18-09
Electronic Orange Book (EOB) Query data files12-18-09
Unapproved Drugs: Drugs Marketed in the United States That Do Not Have Required FDA Approval --12-18-09
Addendum to ICH S6:12-16-09
Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions Annex 12: Analytical Sieving General Chapter12-16-09
Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions Annex 11: Capillary Electrophoresis General Chapter12-16-09
Information for Healthcare Professionals: Update to the labeling of Clopidogrel Bisulfate (marketed as Plavix) to alert healthcare professionals about a drug interaction with omeprazole (marketed as Prilosec and Prilosec OTC)11-17-09
Early Communication about an Ongoing Safety Review of Meridia (sibutramine hydrochloride)11-20-09
Meetings, Conferences, & Workshops (Drugs)12-10-09
Drugs@FDA Data Files12-09-09
Paragraph IV Patent Certifications12-09-09
ANDA (Generic) Drug Approvals12-09-09
PET Drug Products - Current Good Manufacturing Practice (CGMP)12-09-09
Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies Conducted under Section 505A and 505B of the Federal Food, Drug, and Cosmetic Act (the Act), as amended by the FDA Amendments Act of 2007 (FDAAA)12-09-09
Drugs to be Discontinued12-08-09
Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims (final)12-08-09
Current Drug Shortages12-04-09
Pediatric Exclusivity Statistics12-04-09
Written Requests Issued12-04-09
Information for Healthcare Professionals: Risk of Neural Tube Birth Defects following prenatal exposure to Valproate12-03-09
National Drug Code Directory11-30-09
Early Communication about an Ongoing Safety Review of Meridia (sibutramine hydrochloride)11-20-09
Information for Healthcare Professionals: Peramivir IV Renal Dosing Recommendations11-20-09
Warning Letters 200911-20-09
Q8(R2) Pharmaceutical Development11-20-09
Influenza (Flu) Antiviral Drugs and Related Information11-20-09
Follow-Up to the January 26, 2009, Early Communication about an Ongoing Safety Review of Clopidogrel Bisulfate (marketed as Plavix) and Omeprazole (marketed as Prilosec and Prilosec OTC)11-17-09
Public Health Advisory: Updated Safety Information about a drug interaction between Clopidogrel Bisulfate (marketed as Plavix) and Omeprazole (marketed as Prilosec and Prilosec OTC)11-17-09