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FDA Keeps Avandia on the Market, But With Severe Restrictions

September 24, 2010
The FDA has allowed GlaxoSmithKline’s (GSK) diabetes drug Avandia to remain on the market, but with severe restrictions on its access. Under a risk evaluation and mitigation strategy (REMS) to be developed by GSK, Avandia (rosiglitazone) will be available to new patients only if they are unable to achieve glucose control on other medications and are unable to take Takeda’s competing diabetes drug Actos (pioglitazone), the FDA said. Current users of Avandia will be allowed to continue taking the drug but will be required to sign a document acknowledging that they have been made aware of and understand the risks associated with the drug.
Drug Industry Daily