Biovail, Depomed Receive Approvable Letter for Glumetza

Biovail and Depomed have received an approvable letter from the FDA regarding their new drug application for Glumetza, a once-daily, extended-release formulation of metformin HCl for the treatment of Type 2 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, the companies said. Biovail filed its NDA for Glumetza -- in 500-mg and 1,000-mg dosage forms -- in April 2004.