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FDA Replaces Avandia REMS Distribution Restrictions With Prescriber Training

 
• By Sue Sutter

Comforted by the re-adjudicated RECORD results, agency directs rosiglitazone sponsors to provide training “based on the current state of knowledge” about the diabetes drug’s cardiovascular risk but eliminates the requirement that links drug access to provider, pharmacy and patient enrollment in the REMS.

FDA is replacing prescribing and distribution restrictions for rosiglitazone-containing medicines, including GlaxoSmithKline PLC’s Avandia and generics, with a requirement for prescriber training on the current state of knowledge about the diabetes drug’s cardiovascular risks.

The agency’s action amounts to a significant easing of the current REMS restrictions on the thiazolidinedione but not a complete elimination of the program’s elements to assure safe use (ETASU)

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