FDA Drugs- What\'s New News Archive | SourceSolution's Biotech, Pharma, CMO, CRO Directory

News Archive of FDA Drugs- What\'s New

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Comunicado de la FDA sobre la seguridad de los medicamentos: Recomendaciones modificadas para observación cardiovascular y uso del medicamento Gilenya (fingolimod) para la esclerosis múltiple	05-21-12
Comunicado de la FDA sobre la seguridad de los medicamentos: Recomendaciones modificadas para observación cardiovascular y uso del medicamento Gilenya (fingolimod) para la esclerosis múltiple	05-21-12
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 malignancies	05-07-12
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 VIH	05-07-12
Comunicado de la FDA sobre la seguridad de los medicamentos: InformaciÃ³n actualizada sobre la interacciÃ³n entre el medicamento Victrelis (boceprevir) y ciertos medicamentos reforzados inhibidores de la proteasa del VIH	05-07-12
Comunicado de la FDA sobre la seguridad de los medicamentos: Nueva advertencia y contraindicación sobre medicamentos para la presión arterial que contienen aliskiren	05-01-12
Comunicado de la FDA sobre la seguridad de los medicamentos: Nueva advertencia y contraindicación sobre medicamentos para la presión arterial que contienen aliskiren	05-01-12
Webinar: Practical Advice for Preventing Surgical Fires--Safety Strategies from the Front Lines	04-26-12
FDA Drug Safety Communication: Updated information on drug interactions between Victrelis (boceprevir) and certain boosted HIV protease inhibitor drugs	04-26-12
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 drospirenona	04-20-12
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 drospirenona	04-20-12
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 drospirenone	04-10-12
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 altas	04-05-12
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 musculares	04-05-12
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 musculares	04-05-12
FDA Drug Safety Communication: Revised recommendations for Celexa (citalopram hydrobromide) related to a potential risk of abnormal heart rhythms with high doses	03-28-12
Postmarketing Requirements and Commitments: Reports	03-13-12
Comunicado de la FDA sobre la seguridad de los medicamentos: La interacciÃ³n entre ciertos medicamentos para el VIH o hepatitis C y los medicamentos con estatinas para reducir el colesterol, puede aumentar el riesgo de lesiones musculares	03-12-12
Comunicado de la FDA sobre la seguridad de los medicamentos: La interacciÃ³n entre ciertos medicamentos para el VIH o hepatitis C y los medicamentos con estatinas para reducir el colesterol, puede aumentar el riesgo de lesiones musculares	03-12-12
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 estatinas	03-05-12
FDA Drug Safety Communication: Interactions between certain HIV or hepatitis C drugs and cholesterol-lowering statin drugs can increase the risk of muscle injury	03-01-12
FDA Drug Safety Communication: Important safety label changes to cholesterol-lowering statin drugs	02-28-12
CDER World	02-24-12
Comunicado de la FDA sobre la seguridad de los medicamentos: Reingreso planeado al mercado de CardioGen-82 con nuevo recuadro de advertencia	02-23-12
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 ritonavir	02-22-12
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 Warning	02-15-12
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 drugs	02-09-12
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 List	02-08-12
Resources and Tools for Preventing Surgical Fires	02-06-12
Initiative Partners	02-03-12
FDA Drug Safety Communication: New risk factor for Progressive Multifocal Leukoencephalopathy (PML) associated with Tysabri (natalizumab)	01-20-12
Medication Guides	01-17-12
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-82	01-12-12
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) medicines	12-29-11
FDA Alerts Pharmacists and Health Care Professionals to Potential for Injury when Dispensing the Similar-Sounding Drugs Durezol and Durasal	12-28-11
FDA Drug Safety Communication: Addition of another concentration of liquid acetaminophen marketed for infants	12-22-11
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 events	12-19-11
FDA Drug Safety Communication: Revised dose limitation for Zocor (simvastatin) when taken with amiodarone	12-15-11
FDA Drug Safety Communication: Selective serotonin reuptake inhibitor (SSRI) antidepressant use during pregnancy and reports of a rare heart and lung condition in newborn babies	12-14-11
FDA Drug Safety Communication: Safety Review Update of Medications used to treat Attention-Deficit/Hyperactivity Disorder (ADHD) in adults	12-12-11
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 Program	11-04-11
FDA Drug Safety Communication: UPDATE on Tumor Necrosis Factor (TNF) blockers and risk for pediatric malignancy	11-03-11
FDA Drug Safety Communication: Safety Review Update of Medications used to treat Attention-Deficit/Hyperactivity Disorder (ADHD) in children and young adults	11-01-11
Opportunities for Collaboration	10-28-11
FDA Drug Safety Communication: Updated information about the FDA-funded study on risk of blood clots in women taking birth control pills containing drospirenone	10-27-11
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 psiquiátricos	10-26-11
FDA Drug Safety Communication: Safety review update of Chantix (varenicline) and risk of neuropsychiatric adverse events	10-24-11
FDA Drug Safety Communication: Updated information about the drug interaction between linezolid (Zyvox) and serotonergic psychiatric medications	10-20-11
FDA Drug Safety Communication: Updated information about the drug interaction between methylene blue (methylthioninium chloride) and serotonergic psychiatric medications	10-20-11
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 esófago	10-13-11
Comunicado de la FDA sobre la seguridad de los medicamentos: La etiqueta del medicamento Chantix (vareniclina) ahora contiene información actualizada sobre su eficacia y seguridad	10-13-11
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 pioglitazona	10-13-11
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 muerte	10-13-11
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 Fires	10-13-11
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 boca	10-13-11
FDA Drug Safety Communication: Sprycel (dasatinib) and risk of pulmonary arterial hypertension	10-11-11
Questions and Answers - Safety review update on the possible increased risk of blood clots with birth control pills containing drospirenone	09-26-11
FDA Drug Safety Communication: Safety review update on the possible increased risk of blood clots with birth control pills containing drospirenone	09-26-11
Stay Informed about Small Business	09-20-11
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 Shortages	09-09-11
FDA Drug Safety Communication: Drug labels for the Tumor Necrosis Factor-alpha (TNFα) blockers now include warnings about infection with Legionella and Listeria bacteria	09-07-11
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 boca	08-23-11
FDA Alerts Health Care Professionals of Infection Risk from Repackaged Avastin Intravitreal Injections	08-30-11
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 muerte	08-17-11
Comunicado de Seguridad de Medicamentos de la FDA: Actualización de las etiquetas de los medicamentos que contienen pioglitazona	08-17-11
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 muerte	08-17-11
Comunicado de Seguridad de Medicamentos de la FDA: Actualización de las etiquetas de los medicamentos que contienen pioglitazona	08-17-11
Drug Establishment Annual Registration Status Download File	08-15-11
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 psiquiátricos	08-12-11
FDA Drug Safety Communication: Serious CNS reactions possible when linezolid (Zyvox) is given to patients taking certain psychiatric medications	08-12-11
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 seguridad	08-05-11
FDA Drug Safety Communication: Updated drug labels for pioglitazone-containing medicines	08-04-11
FDA Drug Safety Communication: Safety review update of Recombinant Human Growth Hormone (somatropin) and possible increased risk of death	08-04-11
FDA Drug Safety Communication:Use of long-term, high-dose Diflucan (fluconazole) during pregnancy may be associated with birth defects in infants	08-03-11
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 esófago	08-02-11
FDA Drug Safety Communication: Serious CNS reactions possible when methylene blue is given to patients taking certain psychiatric medications	07-26-11
FDA Drug Safety Communication: Serious CNS reactions possible when linezolid (Zyvox®) is given to patients taking certain psychiatric medications	07-26-11
FDA Drug Safety Communication: FDA alerts healthcare professionals to stop performing heart scans with CardioGen-82 due to potential for increased radiation exposure in patients	07-26-11
FDA Drug Safety Communication: Chantix (varenicline) drug label now contains updated efficacy and safety information	07-25-11
FDA Drug Safety Communication: Multaq (dronedarone) and increased risk of death and serious cardiovascular adverse events	07-21-11
FDA Drug Safety Communication: Ongoing safety review of oral osteoporosis drugs (bisphosphonates) and potential increased risk of esophageal cancer	07-21-11
FDA Drug Safety Communication: Increased radiation exposure due to undetected strontium breakthrough when using CardioGen-82 for cardiac positron emission tomography (PET) scans	07-15-11
FDA Drug Safety Communication: Children born to mothers who took Valproate products while pregnant may have impaired cognitive development	06-30-11
Drug Firm Annual Registration Status Download File	06-29-11
FDA Drug Safety Communication: Modified dosing recommendations to improve the safe use of Erythropoiesis-Stimulating Agents (ESAs) in chronic kidney disease	06-24-11
FDA Drug Safety Communication: Chantix (varenicline) may increase the risk of certain cardiovascular adverse events in patients with cardiovascular disease	06-16-11
FDA Drug Safety Communication: Update to ongoing safety review of Actos (pioglitazone) and increased risk of bladder cancer	06-15-11
Questions and Answers: FDA announces new requirements for over-the-counter (OTC) sunscreen products marketed in the U.S.	06-14-11
Sunscreen	06-14-11
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 cancer	06-09-11
FDA Drug Safety Communication: 5-alpha reductase inhibitors (5-ARIs) may increase the risk of a more serious form of prostate cancer	06-09-11
FDA Drug Safety Communication: New restrictions, contraindications, and dose limitations for Zocor (simvastatin) to reduce the risk of muscle injury	06-08-11
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 clots	05-31-11
FDA Drug Safety Communication: Safety Review of possible increased risk of blood clots with birth control pills containing drospirenone	05-31-11
Questions and Answers ? Ongoing safety review of birth control pills containing drospirenone and a possible increased risk of blood clots	05-31-11
FDA Statement on the AIM-HIGH Trial	05-26-11
Chantix: Quarterwatch Article	05-19-11
FDA Drug Safety Communication: Updated Risk Evaluation and Mitigation Strategy (REMS) to Restrict Access to Rosiglitazone-containing Medicines including Avandia, Avandamet, and Avandaryl	05-18-11
Postmarketing Drug Safety Evaluations	05-13-11
FDA Drug Safety Communication: Connection problems involving certain needleless pre-filled glass syringes containing adenosine and amiodarone	05-06-11
Questions and Answers on Guidance for Industry: Dosage Delivery Devices for Orally Ingested OTC Liquid Drug Products	05-04-11
Natural Disaster Response	04-28-11
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 mercaptopurine	04-14-11
FDA Drug Safety Communication: Safety Review Update of Benicar (olmesartan) and cardiovascular events	04-13-11
FDA Drug Safety Communication: Ongoing safety review of Revlimid (lenalidomide) and possible increased risk of developing new malignancies	04-08-11
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 procedures	04-07-11
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 mouth	04-07-11
FDA Drug Safety Communication: Special storage and handling requirements must be followed for Pradaxa (dabigatran etexilate mesylate) capsules	03-29-11
FDA Drug Safety Communication: Serious health problems seen in premature babies given Kaletra (lopinavir/ritonavir) oral solution	03-08-11
FDA Drug Safety Communication: Liver injury warning to be removed from Letairis (ambrisentan) tablets	03-04-11
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 attack	03-02-11
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 newborns	02-22-11
FDA Drug Safety Communication: New warnings against use of terbutaline to treat preterm labor	02-17-11
FDA Drug Safety Communication: Avandia (rosiglitazone) labels now contain updated information about cardiovascular risks and use in certain patients	02-03-11
Warning Letters 2011	01-24-11
FDA Drug Safety Communication: Severe liver injury associated with the use of dronedarone (marketed as Multaq)	01-14-11
Acetaminophen Information	01-13-11
FDA Drug Safety Communication: Update to ongoing safety review of Lantus (insulin glargine) and possible risk of cancer	01-12-11
Safe Use Initiative: FDA-Sponsored Stakeholder Meeting on Surgical Fire Prevention	01-11-11
Midodrine Update: Opening of a public docket	01-11-11
FDA Drug Safety Communication: Ongoing safety review of Recombinant Human Growth Hormone (somatropin) and possible increased risk of death	12-22-10
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 age	12-14-10
FDA Drug Safety Communication: FDA recommends against the continued use of propoxyphene	11-19-10
Safe Use Initiative: Expert Roundtable on Pain Management in Older Adults	11-17-10
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 omeprazole	10-27-10
Safe Use Initiative: Acetaminophen Toxicity	10-25-10
Safe Use Initiative Fact Sheet	10-25-10
Advisory to Drug and Dietary Supplement Manufacturers, Compounding Pharmacies and Distributors of Excipients and Dietary Ingredients ? FDA Detects High Levels of Peroxide in Crospovidone	10-22-10
Advisory to Drug and Dietary Supplement Manufacturers, Compounding Pharmacies and Distributors of Excipients and Dietary Ingredients – FDA Detects High Levels of Peroxide in Crospovidone	10-22-10
FDA Drug Safety Communication: Invirase (saquinavir) labels now contain updated risk information on abnormal heart rhythms	10-19-10
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 Diseases	10-19-10
Questions and Answers on Unapproved Chelation Products	10-14-10
FDA Drug Safety Communication: Safety update for osteoporosis drugs, bisphosphonates, and atypical fractures	10-14-10
FDA Drug Safety Communication: FDA Recommends Against the Continued Use of Meridia (sibutramine)	10-08-10
Safe Use Initiative: Opportunities for Collaboration	10-05-10
Safe Use Initiative	09-20-10
FDA Drug Safety Communication: Ongoing Safety Review of Actos (pioglitazone) and Potential Increased Risk of Bladder Cancer After Two Years Exposure	09-17-10
FDA Drug Safety Communication: New dosing recommendations to prevent potential Valcyte (valganciclovir) overdose in pediatric transplant patients	09-15-10
FDA Statement on ASBMR report: Possible Increased Risk of Certain Types of Thigh Bone Fractures with Long-Term Bisphosphonates Use	09-15-10
Adverse Events Reporting System (AERS) Electronic Submissions	09-13-10
FDA Drug Safety Communication: New warnings for using gadolinium-based contrast agents in patients with kidney dysfunction	09-09-10
Safe Drug Use After a Natural Disaster	09-02-10
Information Regarding Insulin Storage and Switching Between Products in an Emergency	09-02-10
FDA Drug Safety Communication: Increased risk of death with Tygacil (tigecycline) compared to other antibiotics used to treat similar infections	09-01-10
September 20, 2010: Cardiovascular and Renal Drugs Advisory Committee Meeting Announcement	08-27-10
FDA Drug Safety Communication: Ongoing Safety Review of Stalevo and possible increased cardiovascular risk	08-20-10
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 capsules	08-02-10
FDA Drug Safety Communication: Ongoing safety review of Evamist (estradiol transdermal spray) and unintended exposure of children and pets to topical estrogen	07-29-10
FDA Drug Safety Communication: Eosinophilic pneumonia associated with the use of Cubicin (daptomycin)	07-29-10
FDA Statement on Avandia TIDE Trial	07-21-10
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 Attachment	06-22-10
Tamiflu and Relenza Emergency Use Authorization Disposition Letters and Question and Answer Attachments	06-22-10
CDER Key Officials List	06-22-10
Implementation of the Biologics Price Competition and Innovation Act of 2009	06-22-10
Termination of Declarations of Emergency Justifying Emergency Use Authorization (EUA) of Certain Antiviral Drugs—Zanamivir, Oseltamivir Phosphate, and Peramivir	06-22-10
Termination of Declarations of Emergency Justifying Emergency Use Authorization (EUA) of Certain Antiviral Drugs?Zanamivir, Oseltamivir Phosphate, and Peramivir	06-22-10
FDA Drug Safety Communication: Ongoing safety review of Benicar and cardiovascular events	06-11-10
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 Contamination	05-31-10
FDA Public Health Alert: Healthcare Professionals Warned Not To Use Certain Intravenous Metronidazole, Ondansetron, and Ciprofloxacin Due To Contamination	05-30-10
FDA Drug Safety Communication: Completed safety review of Xenical/Alli (orlistat) and severe liver injury	05-26-10
FDA Drug Safety Communication: Possible increased risk of fractures of the hip, wrist, and spine with the use of proton pump inhibitors	05-25-10
CDER Statement to Healthcare Professionals: Restricted Availability of Thyrogen	05-24-10
Updated Questions and Answers for Healthcare Professionals and the Public: Use an Approved Pancreatic Enzyme Product (PEP)	05-24-10
FDA Drug Info Rounds	05-19-10
FDA Drug Safety Communication: Medication errors from swallowing topical Benadryl Extra Strength Itch Stopping Gel	05-12-10
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 diseases	05-03-10
4th Annual FDA/DIA Statistics Forum: Integrating Knowledge in Clinical Development: Meta-analysis, Non-Inferiority, and Related Topics - The FDA/HHS Presentations	04-22-10
FDA Drug Safety Communication: New Boxed Warning on severe liver injury with propylthiouracil	04-21-10
Orange Book Zip File	04-21-10
Disposal by Flushing of Certain Unused Medicines: What You Should Know	04-14-10
Phase-Out of Epinephrine CFC Metered-Dose Inhalers	04-14-10
Phase-Out of Albuterol CFC Metered-Dose Inhalers	04-14-10
Phase-Out of CFC Metered-Dose Inhalers	04-14-10
Phase-Out of CFC Metered-Dose Inhalers Containing flunisolide, triamcinolone, metaproterenol, pirbuterol, albuterol and ipratropium in combination, cromolyn, and nedocromil	04-14-10
Questions and Answers for Healthcare Professionals and the Public: Use an Approved Pancreatic Enzyme Product (PEP)	04-12-10
Written Request Template	04-09-10
FDA Drug Safety Communication: Ongoing safety review of high-dose Zocor (simvastatin) and increased risk of muscle injury	04-08-10
Positron Emission Tomography (PET): Additional Questions and Answers Based on December 9, 2009 Stakeholder Call	04-08-10
FDA Drug Safety Communication: Update: Follow up to the Public Health Alert about Changes to the Heparin Sodium USP Monograph	04-07-10
Question and Answers about Changes to the USP Heparin Monograph	04-07-10
Information for Consumers: What You Should Know about Changes to Heparin	04-07-10
FDA Public Health Alert: Change in Heparin USP Monograph	04-06-10
OxyContin - Questions and Answers	04-05-10
Annex 9: Tablet Friability General Chapter	04-02-10
FDA Drug Safety Communication: Ongoing Safety Review of Stalevo (entacapone/carbidopa/levodopa) and possible development of Prostate Cancer	03-31-10
Newly Added Guidance Documents	03-26-10
Breakdown of FDAAA Completed Pediatric Studies	03-24-10
February 2010: Additions and Deletions to the Drug Product List	03-23-10
Pediatric Exclusivity Granted	03-19-10
FDA Drug Safety Communication: Ongoing safety review of high-dose Zocor* (simvastatin) and increased risk of muscle injury	03-19-10
Pharmacokinetics in Patients with Impaired Renal Function ? Study Design, Data Analysis, and Impact on Dosing and Labeling	03-17-10
List of Determinations Including Written Request	03-17-10
Pharmacokinetics in Patients with Impaired Renal Function — Study Design, Data Analysis, and Impact on Dosing and Labeling	03-17-10
Suitability Petitions	03-16-10
FDA Drug Safety Communication: Reduced effectiveness of Plavix (clopidogrel) in patients who are poor metabolizers of the drug	03-12-10
FDA Drug Safety Communication: Ongoing safety review of oral bisphosphonates and atypical subtrochanteric femur fractures	03-10-10
New and Generic Drug Approvals	03-09-10
Non-Inferiority Clinical Trials	02-26-10
Submission of Documentation in Applications for Parametric Release of Human and Veterinary Drug Products Terminally Sterilized by Moist Heat Processes	02-25-10
FDA Drug Safety Communication: Ongoing safety review of Invirase (saquinavir) and possible association with abnormal heart rhythms	02-23-10
FDA Drug Safety Communication: Ongoing review of Avandia (rosiglitazone) and cardiovascular safety	02-22-10
Potential Signals of Serious Risks/New Safety Information Identified from the Adverse Event Reporting System (AERS) between July - September 2009	02-18-10
Potential Signals of Serious Risks/New Safety Information Identified from the Adverse Event Reporting System (AERS) between January - March 2008	02-18-10
Potential Signals of Serious Risks/New Safety Information Identified from the Adverse Event Reporting System (AERS) between April - June 2008	02-18-10
Potential Signals of Serious Risks/New Safety Information Identified from the Adverse Event Reporting System (AERS) between October - December 2008	02-18-10
Potential Signals of Serious Risks/New Safety Information Identified from the Adverse Event Reporting System (AERS) between January - March 2009	02-18-10
Potential Signals of Serious Risks/New Safety Information Identified from the Adverse Event Reporting System (AERS) between April - June 2009	02-18-10
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 Products	02-18-10
Drug Safety Communication: Erythropoiesis-Stimulating Agents (ESAs): Procrit, Epogen and Aranesp	02-16-10
BMIS Zip Download File	02-11-10
Questions and Answers for Healthcare Professionals: CRESTOR and the JUPITER Trial	02-08-10
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 Names	02-05-10
First-Time Generics - December 2009	02-03-10
Drug Master Files (DMFs)	02-02-10
FDA Technical Briefing on Its FY 2011 Budget Request	01-29-10
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 Drugs	01-26-10
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 sibutramine	01-23-10
Follow-Up to the November 2009 Early Communication about an Ongoing Safety Review of Sibutramine, Marketed as Meridia	01-22-10
The Adverse Event Reporting System (AERS): Latest Quarterly Data Files	01-19-10
The Adverse Event Reporting System (AERS): Latest Quarterly Data Files	01-19-10
FDA Informs Consumers of a Nationwide Voluntary Recall of Certain Tylenol Products	01-15-10
Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book)	01-15-10
Generic Drugs: Information for Industry	01-15-10
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 Download	01-13-10
Warning Letters 2010	01-12-10
Guidance to Pharmacies: Compounding Tamiflu Oral Suspension in Advance to Provide for Multiple Prescriptions	01-11-10
Clinical Investigator Inspection List (CLIIL)	01-08-10
Spectrum of Diseases/Conditions	01-08-10
Planning for the Effects of High Absenteeism to Ensure Availability of Medically Necessary Drug Products	01-07-10
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 Products	12-31-09
Adverse Event Reporting System (AERS) Statistics	12-31-09
Status of OTC Rulemakings	12-29-09
Annex 5: Disintegration Test General Chapter	12-22-09
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 Trial	12-22-09
Annex 8: Sterility Test General Chapter	12-22-09
Additions/Deletions for Prescription and OTC Drug Product Lists	12-18-09
Orange Book Current Cumulative Supplement	12-18-09
Electronic Orange Book (EOB) Query data files	12-18-09
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 Chapter	12-16-09
Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions Annex 11: Capillary Electrophoresis General Chapter	12-16-09
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 Files	12-09-09
Paragraph IV Patent Certifications	12-09-09
ANDA (Generic) Drug Approvals	12-09-09
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 Discontinued	12-08-09
Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims (final)	12-08-09
Current Drug Shortages	12-04-09
Pediatric Exclusivity Statistics	12-04-09
Written Requests Issued	12-04-09
Information for Healthcare Professionals: Risk of Neural Tube Birth Defects following prenatal exposure to Valproate	12-03-09
National Drug Code Directory	11-30-09
Early Communication about an Ongoing Safety Review of Meridia (sibutramine hydrochloride)	11-20-09
Information for Healthcare Professionals: Peramivir IV Renal Dosing Recommendations	11-20-09
Warning Letters 2009	11-20-09
Q8(R2) Pharmaceutical Development	11-20-09
Influenza (Flu) Antiviral Drugs and Related Information	11-20-09
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