FDA Advisory Panel Backs Looser Restrictions On Avandia

After two days of deliberation an FDA advisory panel today recommended that the severe restrictions (REMS) placed on rosiglitazone (Avandia, GlaxoSmithKline) be modified. The vote constitutes a modest revival in fortune for the embattled drug and its maker after many years of controversy and bad news. Only 5 panel members voted to continue the current severe restrictions. One member (the consumer representative) voted for the withdrawal of rosiglitazone. By contrast, 20 members voted to either modify (13 votes) or remove (7 votes) the REMS. But the vote should not be interpreted as a broad statement by the More…
Source: CardioBrief - Category: Cardiology Authors: Tags: Uncategorized Avandia Duke University FDA food and drug administration GlaxoSmithKline Rosiglitazone Source Type: blogs