Type 2 Diabetes Mellitus

• FDA approval · 2020-05-12
  FDA Approved: WELCHOL — Supplemental Application (Cosette Pharmaceuticals, Inc.)

  FDA approved a supplemental application for Welchol (colesevelam hydrochloride) submitted by Cosette Pharmaceuticals, Inc.

• FDA approval · 2020-05-12
  FDA Approved: WELCHOL — Supplemental Application (Cosette Pharmaceuticals, Inc.)

  FDA approved a supplemental application for Welchol (colesevelam hydrochloride) from Cosette Pharmaceuticals, Inc.

• FDA approval · 2020-05-05
  FDA Approved: METFORMIN HYDROCHLORIDE — Supplemental Application (Westminster Pharmaceuticals, LLC)

  FDA approved a supplemental application for metformin hydrochloride from Westminster Pharmaceuticals, expanding/confirming the availability …

• FDA approval · 2020-05-05
  FDA Approved: FARXIGA — Supplemental Application (AstraZeneca Pharmaceuticals LP)

  FDA approved a supplemental application for Farxiga (dapagliflozin) from AstraZeneca, adding/ updating labeling to reflect a new indication …

• FDA approval · 2020-04-09
  FDA Approved: METFORMIN HYDROCHLORIDE — Original Application (Ajanta Pharma USA Inc.)

  FDA approves Ajanta Pharma USA Inc.'s Metformin Hydrochloride as an Original Application (ANDA) for a generic metformin hydrochloride produc…

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• FDA approval · 2020-04-07
  FDA Approved: GLIMEPIRIDE — Supplemental Application (Micro Labs Limited)

  FDA approved a supplemental application for glimepiride from Micro Labs Limited under an ANDA.

• FDA approval · 2020-04-03
  FDA Approved: CYCLOSET — Supplemental Application (Avvisto Therapeutics LLC)

  FDA approved a supplemental application for CYCLOSET (bromocriptine mesylate) submitted by Avvisto Therapeutics LLC.

• FDA approval · 2020-03-30
  FDA Approved: JENTADUETO XR — Supplemental Application (Boehringer Ingelheim Pharmaceuticals, Inc.)

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

• FDA approval · 2020-03-30
  FDA Approved: TRADJENTA — Supplemental Application (Boehringer Ingelheim Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for Tradjenta (linagliptin) from Boehringer Ingelheim Pharmaceuticals, Inc., resulting in an upd…

• FDA approval · 2020-03-30
  FDA Approved: JENTADUETO — Supplemental Application (Boehringer Ingelheim Pharmaceuticals, Inc.)

  FDA approved a supplemental application for JENTADUETO (linagliptin and metformin hydrochloride) from Boehringer Ingelheim, updating the pro…

• FDA approval · 2020-03-16
  FDA Approved: COLESEVELAM HYDROCHLORIDE — Supplemental Application (Glenmark Pharmaceuticals Inc.,USA)

  The FDA approved a supplemental application for colesevelam hydrochloride (Glenmark Pharmaceuticals Inc., USA), updating the product's label…

• FDA approval · 2020-03-16
  FDA Approved: COLESEVELAM HYDROCHLORIDE — Supplemental Application (Ascend Laboratories, LLC)

  The FDA approved a supplemental application for Colesevelam hydrochloride by Ascend Laboratories, LLC.

• FDA approval · 2020-03-03
  FDA Approved: METFORMIN HYDROCHLORIDE ORAL SOLUTION — Original Application (TRUPHARMA, LLC)

  FDA approved a generic metformin hydrochloride oral solution from TRUPHARMA, LLC as an Original ANDA, expanding available metformin formulat…

• FDA approval · 2020-02-28
  FDA Approved: BYETTA — Supplemental Application (AstraZeneca Pharmaceuticals LP)

  FDA approved a supplemental application for BYETTA (exenatide) submitted by AstraZeneca Pharmaceuticals LP. The approval updates the product…

• FDA approval · 2020-02-21
  FDA Approved: TRULICITY — Supplemental Application (Eli Lilly and Company)

  FDA approved a supplemental application for Trulicity (dulaglutide) submitted by Eli Lilly. The approval reflects a change to the product's …

• FDA approval · 2020-02-21
  FDA Approved: PIOGLITAZONE HCL AND METFORMIN HCL — Supplemental Application (Torrent Pharmaceuticals Limited)

  FDA approved Torrent Pharmaceuticals Limited's supplemental application for Pioglitazone HCl and Metformin HCl, a fixed-dose combination pro…

• FDA approval · 2020-02-03
  FDA Approved: DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE — Supplemental Application (Prasco Laboratories)

  FDA approved a supplemental application for a dapagliflozin and metformin hydrochloride combination product from Prasco Laboratories. The pr…

• EMA approval · 2020-01-31
  First oral GLP-1 treatment for type 2 diabetes

  The EMA announces the first oral GLP-1 receptor agonist approved for type 2 diabetes, marking a new oral option in this drug class.

• FDA approval · 2020-01-27
  FDA Approved: TRIJARDY XR — Original Application (Boehringer Ingelheim Pharmaceuticals, Inc.)

  The FDA approved TRIJARDY XR, a fixed-dose combination tablet of empagliflozin, linagliptin, and metformin hydrochloride, in an original app…

• FDA approval · 2020-01-27
  FDA Approved: INVOKAMET — Supplemental Application (Janssen Pharmaceuticals, Inc.)

  FDA approved a supplemental NDA for INVOKAMET (canagliflozin and metformin hydrochloride) from Janssen Pharmaceuticals, Inc. This action con…

• FDA approval · 2020-01-24
  FDA Approved: INVOKAMET XR — Supplemental Application (Janssen Pharmaceuticals, Inc.)

  FDA approved a supplemental application for INVOKAMET XR, a fixed-dose combination of canagliflozin and metformin hydrochloride, submitted b…

• FDA approval · 2020-01-24
  FDA Approved: INVOKAMET — Supplemental Application (Janssen Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for INVOKAMET (canagliflozin and metformin hydrochloride) submitted by Janssen Pharmaceuticals, …

• FDA approval · 2020-01-24
  FDA Approved: DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE — Supplemental Application (Prasco Laboratories)

  The FDA approved a supplemental application for the dapagliflozin and metformin hydrochloride combination product submitted by Prasco Labora…

• FDA approval · 2020-01-24
  FDA Approved: GLYXAMBI — Supplemental Application (Boehringer Ingelheim Pharmaceuticals, Inc.)

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

• FDA approval · 2020-01-24
  FDA Approved: INVOKANA — Supplemental Application (Janssen Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for Invokana (canagliflozin) from Janssen Pharmaceuticals, Inc.