Type 2 Diabetes Mellitus

• FDA approval · 2023-01-17
  FDA Approved: NATEGLINIDE — Supplemental Application (Dr. Reddy's Laboratories Limited)

  FDA approved a supplemental application for NATEGLINIDE by Dr. Reddy's Laboratories Limited.

• FDA approval · 2023-01-12
  FDA Approved: OZEMPIC — Supplemental Application (Novo Nordisk)

  FDA approved a supplemental application for OZEMPIC (oral semaglutide) submitted by Novo Nordisk.

• FDA approval · 2023-01-10
  FDA Approved: METFORMIN HYDROCHLORIDE — Original Application (Micro Labs Limited)

  FDA approved Micro Labs Limited's metformin hydrochloride product under an Original Application (ANDA 212448) for use as a generic treatment…

• FDA approval · 2022-12-21
  FDA Approved: BYETTA — Supplemental Application (AstraZeneca Pharmaceuticals LP)

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

• FDA approval · 2022-12-08
  FDA Approved: LEVEMIR — Supplemental Application (Novo Nordisk)

  The FDA approved a supplemental application for LEVEMIR (insulin detemir) from Novo Nordisk, resulting in labeling changes related to the pr…

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• FDA approval · 2022-11-30
  FDA Approved: APIDRA — Supplemental Application (sanofi-aventis U.S. LLC)

  FDA approved a supplemental application for APIDRA (insulin glulisine) filed by Sanofi‑Aventis U.S. LLC.

• FDA approval · 2022-11-23
  FDA Approved: NOVOLIN 70/30 — Supplemental Application (Novo Nordisk)

  The FDA approved a supplemental application for NOVOLIN 70/30 (human insulin) from Novo Nordisk.

• FDA approval · 2022-11-17
  FDA Approved: TRULICITY — Supplemental Application (Eli Lilly and Company)

  The FDA granted a supplemental approval for TRULICITY (dulaglutide) from Eli Lilly and Company.

• FDA approval · 2022-11-16
  FDA Approved: REZVOGLAR KWIKPEN — Original Application (Eli Lilly and Company)

  FDA approved Rezvoglar KwikPEN (insulin glargine-AGLR) from Eli Lilly as a biosimilar insulin glargine via an Original Application. It is in…

• FDA approval · 2022-11-08
  FDA Approved: BROMOCRIPTINE MESYLATE — Supplemental Application (Sandoz Inc)

  FDA approved a supplemental application for bromocriptine mesylate from Sandoz Inc, approving a modification to an existing generic product'…

• FDA approval · 2022-10-14
  FDA Approved: LYUMJEV — Supplemental Application (Eli Lilly and Company)

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

• FDA approval · 2022-10-13
  FDA Approved: NATEGLINIDE — Supplemental Application (Strides Pharma Science Limited)

  FDA approves a supplemental application for nateglinide by Strides Pharma Science Limited.

• FDA approval · 2022-10-13
  FDA Approved: INVOKAMET — Supplemental Application (Janssen Pharmaceuticals, Inc.)

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

• FDA approval · 2022-10-13
  FDA Approved: DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE — Supplemental Application (Prasco Laboratories)

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

• FDA approval · 2022-10-13
  FDA Approved: GLYXAMBI — Supplemental Application (Boehringer Ingelheim Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for Glyxambi (empagliflozin and linagliptin) from Boehringer Ingelheim, authorizing an additiona…

• FDA approval · 2022-10-13
  FDA Approved: INVOKAMET XR — Supplemental Application (Janssen Pharmaceuticals, Inc.)

  FDA approved a supplemental application for INVOKAMET XR (canagliflozin and metformin hydrochloride) to update the product labeling. The app…

• FDA approval · 2022-10-13
  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 · 2022-10-13
  FDA Approved: STEGLUJAN — Supplemental Application (Merck Sharp & Dohme LLC)

  FDA approves a supplemental application for STEGLUJAN (ertugliflozin and sitagliptin).

• FDA approval · 2022-10-13
  FDA Approved: STEGLATRO — Supplemental Application (Merck Sharp & Dohme LLC)

  The FDA approved a supplemental application for STEGLATRO (ertugliflozin) submitted by Merck Sharp & Dohme LLC.

• FDA approval · 2022-10-13
  FDA Approved: SEGLUROMET — Supplemental Application (Merck Sharp & Dohme LLC)

  FDA granted a supplemental approval for Segluromet, the combination of ertugliflozin and metformin hydrochloride, from Merck Sharp & Dohme L…

• FDA approval · 2022-10-13
  FDA Approved: INVOKANA — Supplemental Application (Janssen Pharmaceuticals, Inc.)

  FDA approved a supplemental application for INVOKANA (canagliflozin) submitted by Janssen Pharmaceuticals, Inc.

• FDA approval · 2022-10-13
  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 · 2022-10-13
  FDA Approved: TRIJARDY XR — Supplemental Application (Boehringer Ingelheim Pharmaceuticals, Inc.)

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

• EMA approval · 2022-09-09
  EMA Authorised: Incresync (alogliptin;pioglitazone) — Takeda Pharma A/S

  The EMA authorised Incresync, a combination product of alogliptin and pioglitazone, for type 2 diabetes mellitus.

• FDA approval · 2022-08-19
  FDA Approved: METFORMIN HYDROCHLORIDE — Original Application (VistaPharm, LLC)

  FDA approved an original application for metformin hydrochloride as a generic product manufactured by VistaPharm, LLC.