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Steglatro Approval History

  • FDA approved: Yes (First approved December 19th, 2017)
  • Brand name: Steglatro
  • Generic name: ertugliflozin
  • Dosage form: Tablets
  • Company: Merck & Co., Inc.
  • Treatment for: Diabetes, Type 2

Steglatro (ertugliflozin) is a sodium-glucose co-transporter-2 (SGLT2) inhibitor used to help improve glycemic control in adults with type 2 diabetes.

Development History and FDA Approval Process for Steglatro

DateArticle
Dec 22, 2017Approval FDA Approves Steglatro (ertugliflozin) for Type 2 Diabetes
Jun 10, 2017Merck and Pfizer Announce that Investigational SGLT-2 Inhibitor Ertugliflozin Met Primary Endpoint in Two Phase 3 Studies
Mar  6, 2017Merck and Pfizer Announce U.S. FDA and EMA Filing Acceptances of Three Marketing Applications for Ertugliflozin-Containing Medicines for Adults with Type 2 Diabetes
Sep 15, 2016Merck and Pfizer Announce Investigational Ertugliflozin Met Primary Endpoint of A1C Reduction When Added to Sitagliptin and Metformin in People with Type 2 Diabetes
Jun 11, 2016Merck and Pfizer Announce Two Pivotal Phase 3 Studies for Ertugliflozin Met Primary Endpoints
Apr 29, 2013Merck & Co., Inc. and Pfizer Enter Worldwide Collaboration Agreement to Develop and Commercialize Ertugliflozin, an Investigational Medicine for Type 2 Diabetes

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