Type 2 Diabetes Mellitus

• FDA approval · 2022-02-03
  FDA Approved: DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE — Supplemental Application (Prasco Laboratories)

  The FDA approved a supplemental application from Prasco Laboratories to market a fixed-dose combination tablet of dapagliflozin and metformi…

• FDA approval · 2021-12-17
  FDA Approved: REZVOGLAR KWIKPEN — Original Application (Eli Lilly and Company)

  The FDA approved Rezvoglar KwikPen (insulin glargine-AGLR) from Eli Lilly as an original application, providing a long-acting insulin option…

• FDA approval · 2021-12-03
  FDA Approved: METFORMIN HYDROCHLORIDE — Original Application (Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.)

  FDA approved an Original Application for Metformin Hydrochloride from Heritage Pharmaceuticals (d/b/a Avet Pharmaceuticals Inc.), enabling t…

• FDA approval · 2021-11-04
  FDA Approved: JANUMET XR — Supplemental Application (Merck Sharp & Dohme LLC)

  The FDA approved a supplemental application for JANUMET XR (sitagliptin and metformin hydrochloride) from Merck Sharp & Dohme LLC.

• FDA approval · 2021-11-04
  FDA Approved: BYETTA — Supplemental Application (AstraZeneca Pharmaceuticals LP)

  The FDA approved a supplemental application for BYETTA (exenatide) from AstraZeneca Pharmaceuticals LP.

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• FDA approval · 2021-11-04
  FDA Approved: JANUMET — Supplemental Application (Merck Sharp & Dohme LLC)

  FDA approves a supplemental application for JANUMET (sitagliptin and metformin hydrochloride) from Merck Sharp & Dohme LLC, marking a labeli…

• FDA approval · 2021-10-22
  FDA Approved: NOVOLOG — Supplemental Application (Novo Nordisk)

  The FDA approved a supplemental application for NovoLog (insulin aspart) from Novo Nordisk. The action updates/expands the drug's approved l…

• FDA approval · 2021-10-20
  FDA Approved: WELCHOL — Supplemental Application (Cosette Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for Welchol (colesevelam hydrochloride) submitted by Cosette Pharmaceuticals, Inc. to update the…

• FDA approval · 2021-10-01
  FDA Approved: JENTADUETO XR — Supplemental Application (Boehringer Ingelheim Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for JENTADUETO XR, a fixed-dose combination of linagliptin and metformin hydrochloride, updating…

• FDA approval · 2021-09-30
  FDA Approved: TRULICITY — Supplemental Application (Eli Lilly and Company)

  FDA approved a supplemental application for TRULICITY (dulaglutide) submitted by Eli Lilly and Company, updating the label as requested in t…

• FDA approval · 2021-09-17
  FDA Approved: STEGLUJAN — Supplemental Application (Merck Sharp & Dohme LLC)

  The FDA approved a supplemental application for STEGLUJAN (ertugliflozin and sitagliptin) from Merck Sharp & Dohme LLC.

• FDA approval · 2021-09-17
  FDA Approved: STEGLATRO — Supplemental Application (Merck Sharp & Dohme LLC)

  FDA approved a supplemental application for STEGLATRO (ertugliflozin) from Merck Sharp & Dohme LLC, resulting in changes to the product’s la…

• FDA approval · 2021-08-31
  FDA Approved: LINAGLIPTIN — Original Application (Sunshine Lake Pharma Co., Ltd.)

  FDA approved the original application for linagliptin by Sunshine Lake Pharma Co., Ltd., delivering a generic version of the DPP-4 inhibitor…

• FDA approval · 2021-08-13
  FDA Approved: LYUMJEV — Supplemental Application (Eli Lilly and Company)

  FDA approved a supplemental application for LYUMJEV (insulin lispro-aabc) from Eli Lilly and Company.

• FDA approval · 2021-08-11
  FDA Approved: METFORMIN HYDROCHLORIDE — Original Application (Unichem Pharmaceuticals (USA), Inc.)

  The FDA approved an original application for a generic metformin hydrochloride product from Unichem Pharmaceuticals (USA), Inc., for the tre…

• FDA approval · 2021-08-03
  FDA Approved: GLUCOTROL XL — Supplemental Application (Roerig)

  The FDA approved a supplemental application for Glucotrol XL (glipizide) submitted by Roerig under NDA 020329.

• FDA approval · 2021-07-28
  FDA Approved: SOLIQUA 100/33 — Supplemental Application (Sanofi-Aventis U.S. LLC)

  The FDA approved a supplemental application for Soliqua 100/33, a fixed-ratio combination of insulin glargine and lixisenatide, submitted by…

• FDA approval · 2021-07-28
  FDA Approved: INSULIN GLARGINE — Original Application (Biocon Biologics Inc.)

  FDA approved Biocon Biologics Inc.'s insulin glargine biosimilar under an Original Application, expanding access to insulin glargine therapy…

• FDA approval · 2021-07-20
  FDA Approved: BASAGLAR KWIKPEN — Supplemental Application (Eli Lilly and Company)

  FDA approved a supplemental application for BASAGLAR KWIKPEN (insulin glargine) from Eli Lilly and Company. The submission status indicates …

• FDA approval · 2021-07-09
  FDA Approved: KERENDIA — Original Application (Bayer HealthCare Pharmaceuticals Inc.)

  FDA approves Kerendia (finerenone) from the original application for adults with chronic kidney disease due to type 2 diabetes mellitus. It …

• FDA approval · 2021-06-28
  FDA Approved: METFORMIN HYDROCHLORIDE — Supplemental Application (Westminster Pharmaceuticals, LLC)

  FDA approved Westminster Pharmaceuticals' supplemental application for Metformin Hydrochloride (generic), confirming the product's continued…

• FDA approval · 2021-06-25
  FDA Approved: METFORMIN HYDROCHLORIDE EXTENDED RELEASE — Supplemental Application (TIME CAP LABORATORIES, INC)

  FDA approved a supplemental application for Metformin Hydrochloride Extended Release from Time Cap Laboratories, Inc., bringing an extended-…

• FDA approval · 2021-06-25
  FDA Approved: METFORMIN HYDROCHLORIDE — Supplemental Application (Westminster Pharmaceuticals, LLC)

  FDA approved Westminster Pharmaceuticals' supplemental application for metformin hydrochloride.

• FDA approval · 2021-06-17
  FDA Approved: BYETTA — Supplemental Application (AstraZeneca Pharmaceuticals LP)

  The FDA approved a supplemental application for BYETTA (exenatide) filed by AstraZeneca Pharmaceuticals LP.

• FDA approval · 2021-06-11
  FDA Approved: SYNJARDY XR — Supplemental Application (Boehringer Ingelheim Pharmaceuticals, Inc.)

  FDA approved a supplemental application for SYNJARDY XR, a fixed-dose combination of empagliflozin and metformin hydrochloride.