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.
FDA Replaces Avandia REMS Distribution Restrictions With Prescriber Training
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.
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