Type 2 Diabetes Mellitus

• FDA approval · 2023-06-29
  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. This notice confirms regula…

• FDA approval · 2023-06-20
  FDA Approved: SYNJARDY XR — Supplemental Application (Boehringer Ingelheim Pharmaceuticals, Inc.)

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

• FDA approval · 2023-06-20
  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 · 2023-06-20
  FDA Approved: JENTADUETO — Supplemental Application (Boehringer Ingelheim Pharmaceuticals, Inc.)

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

• FDA approval · 2023-06-20
  FDA Approved: JENTADUETO XR — Supplemental Application (Boehringer Ingelheim Pharmaceuticals, Inc.)

  FDA approved a supplemental application for JENTADUETO XR (linagliptin and metformin hydrochloride) by Boehringer Ingelheim Pharmaceuticals,…

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• FDA approval · 2023-06-20
  FDA Approved: TRADJENTA — Supplemental Application (Boehringer Ingelheim Pharmaceuticals, Inc.)

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

• FDA approval · 2023-06-20
  FDA Approved: METFORMIN HYDROCHLORIDE — Original Application (VGYAAN Pharmaceuticals LLC)

  The FDA approved an original application for metformin hydrochloride, a generic form of metformin, manufactured by VGYAAN Pharmaceuticals LL…

• FDA approval · 2023-06-07
  FDA Approved: PIOGLITAZONE — Supplemental Application (NorthStar RxLLC)

  FDA approved a supplemental application for Pioglitazone submitted by NorthStar RxLLC.

• FDA approval · 2023-06-07
  FDA Approved: PIOGLITAZONE AND METFORMIN HYDROCHLORIDE — Supplemental Application (Macleods Pharmaceuticals Limited)

  The FDA approved a supplemental application for a Pioglitazone and Metformin Hydrochloride combination tablet from Macleods Pharmaceuticals …

• FDA approval · 2023-06-07
  FDA Approved: METFORMIN HYDROCHLORIDE — Supplemental Application (Macleods Pharmaceuticals Limited)

  FDA approved a supplemental application for METFORMIN HYDROCHLORIDE by Macleods Pharmaceuticals Limited (ANDA206955).

• FDA approval · 2023-06-07
  FDA Approved: METFORMIN HYDROCHLORIDE — Supplemental Application (Macleods Pharmaceuticals Limited)

  The FDA approved a supplemental application for Metformin hydrochloride from Macleods Pharmaceuticals Limited.

• EMA approval · 2023-06-01
  EMA Authorised: Pioglitazone Actavis (pioglitazone hydrochloride) — Actavis Group PTC ehf

  Authorisation granted for Pioglitazone Actavis (pioglitazone hydrochloride) for type 2 diabetes mellitus.

• FDA approval · 2023-05-30
  FDA Approved: INSULIN GLARGINE — Supplemental Application (Biocon Biologics Inc.)

  FDA approved Biocon Biologics Inc.'s supplemental Biologics License Application for insulin glargine-YFGN, a biosimilar insulin glargine pro…

• FDA approval · 2023-05-26
  FDA Approved: INPEFA — Original Application (Lexicon Pharmaceuticals, Inc.)

  FDA approved the original application for INPEFA (sotagliflozin) by Lexicon Pharmaceuticals.

• FDA approval · 2023-05-26
  FDA Approved: METFORMIN HYDROCHLORIDE — Supplemental Application (Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.)

  The FDA approved a supplemental application for Metformin Hydrochloride from Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc., …

• FDA approval · 2023-04-11
  FDA Approved: COLESEVELAM HYDROCHLORIDE — Supplemental Application (Glenmark Pharmaceuticals Inc., USA)

  FDA approved Glenmark's supplemental ANDA for Colesevelam Hydrochloride, allowing the marketing of a generic Colesevelam Hydrochloride produ…

• FDA approval · 2023-03-22
  FDA Approved: REPAGLINIDE — Original Application (Macleods Pharmaceuticals Limited)

  FDA approved Macleods Pharmaceuticals Limited's original Abbreviated New Drug Application for repaglinide, a meglitinide used to improve gly…

• FDA approval · 2023-03-13
  FDA Approved: GLIPIZIDE — Supplemental Application (Aurobindo Pharma Limited)

  The FDA approved a supplemental application for GLIPIZIDE from Aurobindo Pharma Limited. This action authorizes marketing of the generic gli…

• FDA approval · 2023-02-28
  FDA Approved: NOVOLOG — Supplemental Application (Novo Nordisk)

  The FDA approved a supplemental application for NovoLog (insulin aspart) filed by Novo Nordisk.

• FDA approval · 2023-02-28
  FDA Approved: INSULIN ASPART PROTAMINE AND INSULIN ASPART MIX 70/30 — Supplemental Application (Novo Nordisk Pharma, Inc.)

  FDA approved a supplemental application for the insulin aspart protamine and insulin aspart mix 70/30 product (brand NovoLOG Mix 70/30) from…

• FDA approval · 2023-02-15
  FDA Tentative Approval: SAXAGLIPTIN — Original Application (Glenmark Pharmaceuticals Inc., USA)

  FDA tentatively approves Glenmark's generic saxagliptin (SAXAGLIPTIN) under an ANDA for type 2 diabetes mellitus, subject to patent and excl…

• FDA approval · 2023-02-06
  FDA Approved: SYNJARDY — Supplemental Application (Boehringer Ingelheim Pharmaceuticals, Inc.)

  FDA approves a supplemental application for Synjardy (empagliflozin and metformin hydrochloride) submitted by Boehringer Ingelheim Pharmaceu…

• FDA approval · 2023-02-06
  FDA Approved: SYNJARDY XR — Supplemental Application (Boehringer Ingelheim Pharmaceuticals, Inc.)

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

• FDA approval · 2023-02-03
  FDA Approved: AFREZZA — Supplemental Application (Mannkind Corporation)

  The FDA approved a supplemental application for AFREZZA (insulin human) from MannKind Corporation.

• FDA approval · 2023-01-19
  FDA Approved: NATEGLINIDE — Supplemental Application (Modavar Pharmaceuticals LLC)

  The FDA approved a supplemental application for nateglinide submitted by Modavar Pharmaceuticals LLC.