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Avandia Re-Adjudication Might Result In “Refreshing” Restricted Distribution Roll Back

 
• By Cathy Dombrowski

More than half of a 26-member advisory committee supports eliminating or easing the REMS for GSK’s diabetes drug, but the spilt vote and high-profile of the product’s safety issues suggest that FDA is unlikely to modify Avandia’s risk management.

GlaxoSmithKline PLC’s Avandia (rosiglitazone) could join the small list of drugs that have had Elements To Assure Safe Use removed from their Risk Evaluation and Mitigation Strategies, or at least have them eased, if FDA follows recommendations from its Endocrinologic and Metabolic Drugs and Drug Safety and Risk Management Advisory Committees.

More than half of a 26-member joint panel backed elimination of the REMS or modifications to make it less restrictive, following a June 5-6 reassessment of the diabetes drug’s cardiovascular safety in light of the re-adjudication of CV events in the RECORD trial Also see "

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• By Bridget Silverman

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