Drug Development

FDA grants approvable letter for extended-release Glumetza for diabetes

Published in Biotech Business Week, March 28th, 2005

Biovail Corporation (BVF) and Depomed, Inc., (DEPO) announced that they have received an Approvable Letter from the U.S. Food and Drug Administration (FDA) regarding a New Drug Application (NDA) for Glumetza, a once-daily, extended-release formulation of metformin hydrochloride (HCl) for the treatment of Type II diabetes.

The letter indicated that Glumetza is approvable pending the completion of discussions with regard to an issue related to finalizing one manufacturing specification. Biovail anticipates submitting a response to the FDA in the coming weeks. No clinical or labeling issues were identified in the letter.

Biovail's NDA for Glumetza - in...

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Source: Biotech Business Week (2005-03-28)

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