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Glumetza Approval History

FDA Approved: Yes (First approved June 3, 2005)
Brand name: Glumetza
Generic name: metformin extended release
Dosage form: Tablets
Company: Biovail Corporation/Depomed, Inc.
Treatment for: Diabetes, Type 2

Glumetza (metformin extended-release) is a once-daily oral antihyperglycemic formulation indicated for the treatment of type 2 diabetes.

Development History and FDA Approval Process for Glumetza

DateArticle
Jan  2, 2008Approval Depomed Receives FDA Approval for 1000 mg Strength Tablets of Glumetza
Jun  3, 2005Approval FDA Approves Glumetza for Type 2 Diabetes
Apr 13, 2005Depomed, Biovail Update Status of Glumetza NDA
Mar  1, 2005Biovail, Depomed Receive Approvable Letter from FDA for Extended-Release Glumetza for Type II Diabetes
Jun 24, 2004Biovail, Depomed Announce Glumetza NDA Accepted by FDA
Apr 28, 2004Biovail and Depomed Submit NDA for Glumetza; Submission Includes 500mg and 1000mg dosages; Biovail/Depomed Expand Royalty Agreement to Include 1000mg dose

Further information

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