Type 2 Diabetes Mellitus

• FDA approval · 2024-08-22
  FDA Approved: NATEGLINIDE — Supplemental Application (Zydus Lifesciences Limited)

  The FDA granted a supplemental approval for Nateglinide from Zydus Lifesciences Limited under an ANDA.

• FDA approval · 2024-08-09
  FDA Approved: REZVOGLAR KWIKPEN — Supplemental Application (Eli Lilly and Company)

  The FDA approved a supplemental application for Rezvoglar KwikPen (insulin glargine-AGLR) from Eli Lilly and Company.

• FDA approval · 2024-07-18
  FDA Approved: ZITUVIMET XR — Original Application (Zydus Pharmaceuticals USA Inc.)

  FDA approved ZITUVIMET XR (sitagliptin and metformin hydrochloride) as an extended-release fixed-dose combination for adults with type 2 dia…

• FDA approval · 2024-07-15
  FDA Approved: GLIPIZIDE — Supplemental Application (Advagen Pharma Limited)

  FDA approves a supplemental application for glipizide from Advagen Pharma Limited.

• FDA approval · 2024-06-28
  FDA Approved: ALOGLIPTIN AND PIOGLITAZONE — Supplemental Application (Padagis Israel Pharmaceuticals Ltd)

  FDA approved a supplemental application for the combination product alogliptin and pioglitazone from Padagis Israel Pharmaceuticals Ltd.

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• FDA approval · 2024-06-28
  FDA Approved: ACTOPLUS MET — Supplemental Application (Takeda Pharmaceuticals America, Inc.)

  The FDA approved a supplemental application for Actoplus Met (pioglitazone and metformin hydrochloride) from Takeda Pharmaceuticals America,…

• FDA approval · 2024-06-20
  FDA Approved: PIOGLITAZONE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved Teva Pharmaceuticals USA, Inc.'s supplemental application for Pioglitazone (generic) under ANDA077210.

• FDA approval · 2024-06-12
  FDA Approved: DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE — Supplemental Application (Prasco Laboratories)

  FDA approved a supplemental application for a dapagliflozin and metformin hydrochloride combination product manufactured by Prasco Laborator…

• FDA approval · 2024-06-04
  FDA Approved: METFORMIN HYDROCHLORIDE — Supplemental Application (Mylan Pharmaceuticals Inc.)

  The FDA granted supplemental approval for Metformin Hydrochloride under an ANDA held by Mylan Pharmaceuticals Inc. This represents regulator…

• EMA approval · 2024-05-13
  EMA Authorised: Onglyza (saxagliptin) — AstraZeneca AB

  Onglyza (saxagliptin) has been authorised in the European Union for the treatment of type 2 diabetes mellitus, by AstraZeneca AB.

• FDA approval · 2024-03-29
  FDA Approved: METFORMIN HYDROCHLORIDE — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for Metformin hydrochloride from Aurobindo Pharma Limited, making a generic version available.

• FDA approval · 2024-01-24
  FDA Approved: OZEMPIC — Supplemental Application (Novo Nordisk)

  FDA approved a supplemental application for Ozempic to include the oral formulation of semaglutide. This adds an oral option alongside the e…

• FDA approval · 2024-01-19
  FDA Approved: INVOKAMET XR — Supplemental Application (Janssen Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for Invokamet XR (canagliflozin and metformin hydrochloride) from Janssen Pharmaceuticals, Inc.

• FDA approval · 2024-01-05
  FDA Approved: METFORMIN HYDROCHLORIDE — Supplemental Application (Laurus Labs Limited)

  The FDA approved a supplemental application for metformin hydrochloride submitted by Laurus Labs Limited.

• FDA approval · 2024-01-03
  FDA Approved: METFORMIN HYDROCHLORIDE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved a supplemental application for metformin hydrochloride from Sun Pharmaceutical Industries, Inc., confirming its status as an ap…

• FDA approval · 2023-12-28
  FDA Approved: JANUVIA — Supplemental Application (Merck Sharp & Dohme LLC)

  The FDA approved a supplemental application for Januvia (sitagliptin) filed by Merck Sharp & Dohme LLC.

• FDA approval · 2023-11-29
  FDA Approved: INSULIN GLARGINE — Supplemental Application (Biocon Biologics Inc.)

  FDA approved Biocon Biologics' supplemental application for INSULIN GLARGINE-YFGN (insulin glargine).

• FDA approval · 2023-11-03
  FDA Approved: SITAGLIPTIN AND METFORMIN HYDROCHLORIDE — Original Application (Zydus Lifesciences Limited)

  FDA approved a fixed-dose combination of sitagliptin and metformin hydrochloride under an Original Application from Zydus Lifesciences Limit…

• FDA approval · 2023-10-30
  FDA Approved: SYNJARDY — Supplemental Application (Boehringer Ingelheim Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for Synjardy (empagliflozin and metformin hydrochloride) from Boehringer Ingelheim Pharmaceutica…

• FDA approval · 2023-10-30
  FDA Approved: TRIJARDY XR — Supplemental Application (Boehringer Ingelheim Pharmaceuticals, Inc.)

  FDA approved a supplemental application for TRIJARDY XR (empagliflozin, linagliptin, metformin hydrochloride) from Boehringer Ingelheim Phar…

• FDA approval · 2023-10-30
  FDA Approved: GLYXAMBI — Supplemental Application (Boehringer Ingelheim Pharmaceuticals, Inc.)

  FDA approved a supplemental application for GLYXAMBI (empagliflozin and linagliptin) from Boehringer Ingelheim Pharmaceuticals, Inc.

• FDA approval · 2023-10-30
  FDA Approved: SYNJARDY XR — Supplemental Application (Boehringer Ingelheim Pharmaceuticals, Inc.)

  FDA approved a supplemental application for SYNJARDY XR (empagliflozin/metformin hydrochloride) from Boehringer Ingelheim Pharmaceuticals, u…

• FDA approval · 2023-10-18
  FDA Approved: SITAGLIPTIN — Original Application (Zydus Lifesciences Limited)

  FDA approved a sitagliptin product under an Original Application from Zydus Lifesciences Limited for type 2 diabetes mellitus.

• FDA approval · 2023-10-05
  FDA Approved: METFORMIN HYDROCHLORIDE — Original Application (Laurus Labs Limited)

  FDA approved Laurus Labs Limited's original application for metformin hydrochloride, a generic version of the diabetes medicine used to trea…

• FDA approval · 2023-10-04
  FDA Approved: COLESEVELAM HCL — Supplemental Application (Ascend Laboratories, LLC)

  The FDA approved a supplemental application for Colesevelam HCl submitted by Ascend Laboratories, LLC, as part of the generic drug approval …