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Glumetza Approval History

  • FDA approved: Yes (First approved June 3rd, 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

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

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