ARTICLE | Company News

Depomed, Biovail submit Glumetza response

April 14, 2005 1:19 AM UTC

DEPO and Biovail (TSE:BVF; BVF) said that on April 8, they submitted a response to an approvable letter from FDA for Glumetza to treat Type II diabetes. Last month, the companies said FDA indicated that the once-daily extended-release formulation of metformin was approvable pending finalization of one manufacturing specification (see BioCentury Extra, Tuesday March 1, 2005). DEPO and BVF believe the response will be considered a Class I submission, with a 60-day review period. DEPO is eligible for a $25 million milestone from Biovail within 30 days of approval. ...