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Invokamet Approval History

FDA Approved: Yes (First approved August 8, 2014)
Brand name: Invokamet
Generic name: canagliflozin and metformin
Dosage form: Tablets
Company: Janssen Pharmaceuticals, Inc.
Treatment for: Diabetes, Type 2, Cardiovascular Risk Reduction

Invokamet (canagliflozin/metformin) is a selective sodium glucose co-transporter 2 (SGLT2) inhibitor and biguanide combination indicated for the treatment of type 2 diabetes, and to reduce the risk of cardiovascular events (including heart attack, stroke or death) in adults with type 2 diabetes and established cardiovascular disease.

Development History and FDA Approval Process for Invokamet

DateArticle
Oct 30, 2018Approval FDA Approves Invokana (canagliflozin) to Reduce the Risk of Heart Attack, Stroke or Cardiovascular Death in Adults with Type 2 Diabetes and Established Cardiovascular Disease
Sep 21, 2016Approval FDA Approves Invokamet XR (Canagliflozin/Metformin Hydrochloride Extended-Release) for the Treatment of Adults with Type 2 Diabetes
May 24, 2016Approval FDA Expands Indication of Invokamet (canagliflozin/metformin HCl) to Include First-Line Treatment of Type 2 Diabetes
Aug 11, 2014Approval FDA Approves Invokamet (canagliflozin/metformin) for Type 2 Diabetes
Dec 12, 2013FDA Issues Complete Response Letter for Canagliflozin/Metformin Fixed-Dose Combination Therapy for Type 2 Diabetes
Dec 12, 2012Janssen Research & Development Submits New Drug Application to U.S. FDA for Canagliflozin/Metformin Fixed-Dose Combination Therapy to Treat Patients with Type 2 Diabetes

Further information

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