Type 2 Diabetes Mellitus

• FDA approval · 2022-08-16
  FDA Approved: TOUJEO — Supplemental Application (Sanofi-Aventis U.S. LLC)

  The FDA approved a supplemental application for TOUJEO (insulin glargine) from Sanofi-Aventis U.S. LLC, resulting in updated labeling for th…

• FDA approval · 2022-07-01
  FDA Approved: TRESIBA — Supplemental Application (Novo Nordisk)

  FDA approved a supplemental application for TRESIBA (insulin degludec) by Novo Nordisk.

• FDA approval · 2022-07-01
  FDA Approved: GLIPIZIDE — Supplemental Application (Rising Pharma Holdings, Inc.)

  FDA approves a supplemental application for Glipizide from Rising Pharma Holdings, Inc., a generic antidiabetic medication.

• FDA approval · 2022-06-21
  FDA Approved: JANUMET — Supplemental Application (Merck Sharp & Dohme LLC)

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

• FDA approval · 2022-06-21
  FDA Approved: JANUMET XR — Supplemental Application (Merck Sharp & Dohme LLC)

  FDA approved a supplemental application for JANUMET XR (sitagliptin and metformin hydrochloride) submitted by Merck Sharp & Dohme LLC, expan…

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• FDA approval · 2022-06-21
  FDA Approved: STEGLUJAN — Supplemental Application (Merck Sharp & Dohme LLC)

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

• FDA approval · 2022-06-10
  FDA Approved: TRULICITY — Supplemental Application (Eli Lilly and Company)

  The FDA approved a supplemental application for Trulicity (dulaglutide) from Eli Lilly and Company.

• FDA approval · 2022-06-10
  FDA Approved: SOLIQUA 100/33 — Supplemental Application (Sanofi-Aventis U.S. LLC)

  The FDA approved a supplemental application for Soliqua 100/33 (insulin glargine and lixisenatide) submitted by Sanofi-Aventis U.S. LLC. Thi…

• FDA approval · 2022-06-10
  FDA Approved: XULTOPHY 100/3.6 — Supplemental Application (Novo Nordisk)

  The FDA approved a supplemental application to add XULTOPHY 100/3.6, a fixed-ratio combination of insulin degludec and liraglutide, for adul…

• FDA approval · 2022-06-10
  FDA Approved: OZEMPIC — Supplemental Application (Novo Nordisk)

  FDA approved a supplemental application for the oral formulation of OZEMPIC (semaglutide) by Novo Nordisk.

• FDA approval · 2022-06-10
  FDA Approved: BYETTA — Supplemental Application (AstraZeneca Pharmaceuticals LP)

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

• FDA approval · 2022-06-09
  FDA Approved: METFORMIN HYDROCHLORIDE — Original Application (Solco Healthcare US, LLC.)

  FDA approved the Original Application for Metformin Hydrochloride from Solco Healthcare US, LLC., enabling a generic metformin hydrochloride…

• FDA approval · 2022-06-07
  FDA Approved: LANTUS SOLOSTAR — Supplemental Application (sanofi-aventis U.S. LLC)

  The FDA approved a supplemental application for LANTUS SOLOSTAR (insulin glargine) from Sanofi-Aventis U.S. LLC, authorizing changes to the …

• FDA approval · 2022-05-13
  FDA Approved: MOUNJARO — Original Application (Eli Lilly and Company)

  FDA approved MOUNJARO (tirzepatide) from Eli Lilly under Original Application NDA 215866 for adults with type 2 diabetes mellitus to improve…

• FDA approval · 2022-04-15
  FDA Approved: JENTADUETO — Supplemental Application (Boehringer Ingelheim Pharmaceuticals, Inc.)

  The FDA approved a supplemental NDA for JENTADUETO (linagliptin and metformin hydrochloride) from Boehringer Ingelheim Pharmaceuticals, Inc.…

• FDA approval · 2022-04-11
  FDA Approved: DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE — Supplemental Application (Prasco Laboratories)

  The FDA approved a supplemental application to authorize a fixed-dose combination tablet of dapagliflozin and metformin hydrochloride for ty…

• FDA approval · 2022-03-28
  FDA Approved: OZEMPIC — Supplemental Application (Novo Nordisk)

  FDA approved Novo Nordisk's supplemental application for Ozempic (semaglutide). The approval updates the product labeling.

• FDA approval · 2022-03-21
  FDA Approved: SYNJARDY — Supplemental Application (Boehringer Ingelheim Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for Synjardy (empagliflozin and metformin hydrochloride) submitted by Boehringer Ingelheim Pharm…

• FDA approval · 2022-03-21
  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, I…

• FDA approval · 2022-03-11
  FDA Approved: KAZANO — Supplemental Application (Takeda Pharmaceuticals America, Inc.)

  FDA approved a supplemental application for KAZANO (alogliptin and metformin hydrochloride) filed by Takeda Pharmaceuticals America, Inc.

• FDA approval · 2022-03-11
  FDA Approved: ALOGLIPTIN AND PIOGLITAZONE — Supplemental Application (Padagis Israel Pharmaceuticals Ltd)

  FDA approved a supplemental application for the fixed-dose combination of alogliptin and pioglitazone (alogliptin benzoate and pioglitazone …

• FDA approval · 2022-03-11
  FDA Approved: ALOGLIPTIN — Supplemental Application (Padagis Israel Pharmaceuticals Ltd)

  The FDA approved a supplemental application for alogliptin filed by Padagis Israel Pharmaceuticals Ltd, representing an additional regulator…

• FDA approval · 2022-03-02
  FDA Approved: STEGLUJAN — Supplemental Application (Merck Sharp & Dohme LLC)

  The FDA approved a supplemental application for STEGLUJAN, a fixed-dose combination of ertugliflozin and sitagliptin. The submission was fil…

• FDA approval · 2022-02-24
  FDA Approved: JARDIANCE — Supplemental Application (Boehringer Ingelheim Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for Jardiance (empagliflozin) submitted by Boehringer Ingelheim Pharmaceuticals, Inc.

• FDA approval · 2022-02-22
  FDA Approved: METFORMIN HYDROCHLORIDE — Original Application (ScieGen Pharmaceuticals, Inc.)

  FDA approved the original application for metformin hydrochloride extended-release tablets from ScieGen Pharmaceuticals, a generic version o…