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Synjardy Approval History

  • FDA approved: Yes (First approved August 26th, 2015)
  • Brand name: Synjardy
  • Generic name: empagliflozin and metformin
  • Dosage form: Tablets
  • Company: Eli Lilly and Company and Boehringer Ingelheim
  • Treatment for: Diabetes, Type 2

Synjardy (empagliflozin and metformin hydrochloride) is a sodium glucose co-transporter-2 (SGLT2) inhibitor and biguanide combination for the treatment of adults with type 2 diabetes.

Development History and FDA Approval Process for Synjardy

Dec 12, 2016Approval FDA Approves Synjardy XR (empagliflozin/metformin hydrochloride extended-release) for Adults with Type 2 Diabetes
Jul 19, 2016Approval FDA Expands Indication For Type 2 Diabetes Treatment Synjardy (Empagliflozin/Metformin Hydrochloride) To Include Treatment-Naïve Adults
Aug 27, 2015Approval FDA Approves Synjardy (empagliflozin/metformin hydrochloride) for Type 2 Diabetes
Oct 21, 2014U.S. FDA Accepts Filing Of NDA for Empagliflozin/Metformin Fixed-Dose Combination

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