10/19/2005 5:13:16 PM
MENLO PARK, Calif.--(BUSINESS WIRE)--April 13, 2005--Depomed, Inc. (NASDAQ:DEPO) and Biovail Corporation (NYSE:BVF)(TSX:BVF) today announced that a response has been submitted to the United States Food and Drug Administration (FDA) regarding an outstanding inquiry on the New Drug Application (NDA) for Glumetza(TM), a once-daily, extended-release formulation of metformin hydrochloride (HCl) for the treatment of Type II diabetes.
Last month, the companies announced that the NDA for Glumetza was deemed "Approvable" by the FDA, pending the resolution of an issue related to finalizing a manufacturing specification. This issue was addressed in a response which was filed at the FDA on April 8, 2005. Depomed and Biovail believe that the response will be considered as a Class I response, which carries a 60-day review period. Within 30 days of final approval, Biovail will make a $25 million milestone payment to Depomed.
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