Generic Drugs: Information for Industry

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Chantix: Quarterwatch Article

May 19, 2011 FDA Statement In 2006, the Pfizer product, Chantix (varenicline), was FDA-approved as a smoking cessation aid. Soon after marketing, FDA became aware through its postmarketing surveillance system, the Adverse Events Reporting System or AERS, of the potential for serious neuropsychiatric events in patients taking Chantix. Subsequently, FDA began communicating about these potential…

FDA Drug Safety Communication: Updated Risk Evaluation and Mitigation Strategy (REMS) to Restrict Access to Rosiglitazone-containing Medicines including Avandia, Avandamet, and Avandaryl

Safety AnnouncementAdditional Information for PatientsAdditional Information for Healthcare ProfessionalsData SummaryReferences   September 23, 2010.   FDA has modified the REMS for Avandamet and Avandaryl because previously, the REMS consisted of only a Medication Guide. The REMS, which now includes a restricted access and distribution program, applies to all three rosiglitazone products. The REMS, called the Avandia-Rosiglitazone…

Postmarketing Drug Safety Evaluations

What is FDA Posting? Why is FDA posting this summary information? What information is provided on this web site? What information does FDA consider for these postmarketing safety evaluations? How is the information analyzed? Postmarketing Drug Safety Evaluation Summaries October 2010 – December 2010 January 2010 – September 2010    What is FDA posting? This…

FDA Drug Safety Communication: Connection problems involving certain needleless pre-filled glass syringes containing adenosine and amiodarone

  Safety AnnouncementAdditional Information for Healthcare Professionals Data SummaryList of Affected Adenosine and Amiodarone ProductsIV Access Systems Known to be Incompatible with Adenosine and Amiodarone Pre-filled Glass SyringesReferences   Safety Announcement [05-06-2011] The U.S. Food and Drug Administration (FDA) is alerting the healthcare community about syringe connection problems when certain needleless glass syringes containing the…

Questions and Answers on Guidance for Industry: Dosage Delivery Devices for Orally Ingested OTC Liquid Drug Products

On May 4, 2011, the U.S. Food and Drug Administration (FDA) issued a final guidance for industry with the Agency’s recommendations for improving dosage delivery devices, such as cups and droppers, for over-the-counter (OTC) (i.e., non-prescription) orally ingested liquid drug products.  The intent of this guidance is to suggest ways manufacturers can improve their labeling…

Natural Disaster Response

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FDA Drug Safety Communication: Safety update on Progressive Multifocal Leukoencephalopathy (PML) associated with Tysabri (natalizumab)

  Safety AnnouncementAdditional Information for PatientsAdditional Information for Healthcare ProfessionalsData Summary   Safety Announcement [04-22-2011] The U.S. Food and Drug Administration (FDA) continues to evaluate the risk of progressive multifocal leukoencephalopathy (PML), a rare but serious brain infection, associated with use of Tysabri (natalizumab) for the treatment of multiple sclerosis (MS) and Crohn’s disease. The…