![FDA, FTC and DOJ Enforcement of Medical Device Regulations FDA, FTC and DOJ Enforcement of Medical Device Regulations](https://www.fdanews.com/ext/resources/Book-Covers-2/BFFDEMDR-COVER.png?height=200&t=1685733565&width=200)
Home » Biovail, Depomed Receive Approvable Letter for Glumetza
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.
KEYWORDS Drug Pipeline Alert
Upcoming Events
-
11Jul
-
18Jul
-
21Oct