Type 2 Diabetes Mellitus

• FDA approval · 2023-10-03
  FDA Approved: GLIPIZIDE — Original Application (Advagen Pharma Limited)

  The FDA approved Advagen Pharma Limited's original application for glipizide (generic). It confirms availability of a generic formulation in…

• FDA approval · 2023-09-28
  FDA Approved: SOLIQUA 100/33 — Supplemental Application (Sanofi-Aventis U.S. LLC)

  FDA approves the supplemental application for SOLIQUA 100/33 (insulin glargine and lixisenatide) from Sanofi-Aventis U.S. LLC.

• FDA approval · 2023-09-22
  FDA Approved: OZEMPIC — Supplemental Application (Novo Nordisk)

  FDA approved a supplemental application for Ozempic (semaglutide) from Novo Nordisk.

• EMA approval · 2023-09-13
  EMA Authorised: Tandemact (pioglitazone;glimepiride) — CHEPLAPHARM Arzneimittel GmbH

  EMA has authorised Tandemact (pioglitazone; glimepiride) for type 2 diabetes mellitus under CHEPLAPHARM Arzneimittel GmbH.

• FDA approval · 2023-09-12
  FDA Approved: JARDIANCE — Supplemental Application (Boehringer Ingelheim Pharmaceuticals, Inc.)

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

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• FDA approval · 2023-09-12
  FDA Approved: DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE — Supplemental Application (Prasco Laboratories)

  FDA approved a supplemental application from Prasco Laboratories for a fixed-dose combination tablet of dapagliflozin and metformin hydrochl…

• FDA approval · 2023-09-12
  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 · 2023-09-12
  FDA Approved: SEGLUROMET — Supplemental Application (Merck Sharp & Dohme LLC)

  The FDA approved a supplemental application for Segluromet, a fixed-dose combination of ertugliflozin and metformin hydrochloride by Merck S…

• EMA approval · 2023-08-28
  EMA Authorised: Actos (pioglitazone hydrochloride) — CHEPLAPHARM Arzneimittel GmbH

  EMA authorises Actos (pioglitazone hydrochloride) for diabetes mellitus type 2 through CHEPLAPHARM Arzneimittel GmbH.

• FDA approval · 2023-08-09
  FDA Approved: SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE — Original Application (Dr.Reddys Laboratories Inc)

  FDA approved the original application for saxagliptin and metformin hydrochloride tablets from Dr. Reddy's Laboratories Inc.

• FDA approval · 2023-07-31
  FDA Approved: SAXAGLIPTIN — Original Application (Mylan Pharmaceuticals Inc.)

  FDA approved the original application for saxagliptin by Mylan Pharmaceuticals Inc., enabling a generic version of the diabetes medication f…

• FDA approval · 2023-07-31
  FDA Approved: SAXAGLIPTIN — Original Application (Aurobindo Pharma Limited)

  The FDA approved a new original ANDA for saxagliptin from Aurobindo Pharma Limited, providing a generic version of the diabetes medication.

• FDA approval · 2023-07-31
  FDA Approved: SAXAGLIPTIN — Original Application (Glenmark Pharmaceuticals Inc., USA)

  The FDA approved Glenmark's original Abbreviated New Drug Application for saxagliptin (generic) to treat type 2 diabetes mellitus.

• FDA approval · 2023-07-31
  FDA Approved: SAXAGLIPTIN AND METFORMIN — Original Application (Mylan Pharmaceuticals Inc.)

  The FDA approved the original application for a generic fixed-dose combination of saxagliptin and metformin (SAXAGLIPTIN AND METFORMIN) from…

• FDA approval · 2023-07-27
  FDA Approved: ALOGLIPTIN — Supplemental Application (Padagis Israel Pharmaceuticals Ltd)

  The FDA approved a supplemental application for alogliptin by Padagis Israel Pharmaceuticals Ltd.

• FDA approval · 2023-07-27
  FDA Approved: KAZANO — Supplemental Application (Takeda Pharmaceuticals America, Inc.)

  FDA approved a supplemental application for Kazano (alogliptin/metformin hydrochloride) submitted by Takeda Pharmaceuticals America, Inc.

• EMA approval · 2023-07-21
  EMA Authorised: Vipidia (alogliptin) — Takeda Pharma A/S

  The EMA authorises Vipidia (alogliptin) for type 2 diabetes mellitus, with Takeda Pharma A/S as the marketing authorization holder.

• FDA approval · 2023-07-21
  FDA Approved: INSULIN LISPRO — Supplemental Application (Eli Lilly and Company)

  FDA approves a supplemental application for insulin lispro submitted by Eli Lilly and Company.

• FDA approval · 2023-07-21
  FDA Approved: HUMALOG MIX50/50 KWIKPEN — Supplemental Application (Eli Lilly and Company)

  The FDA approved a supplemental application for Humalog Mix50/50 KwikPen (insulin lispro) from Eli Lilly and Company. Insulin lispro is used…

• FDA approval · 2023-07-21
  FDA Approved: HUMALOG KWIKPEN — Supplemental Application (Eli Lilly and Company)

  FDA approved a supplemental application for HUMALOG KWIKPEN (insulin lispro) from Eli Lilly and Company.

• FDA approval · 2023-07-21
  FDA Approved: HUMALOG MIX75/25 — Supplemental Application (Eli Lilly and Company)

  FDA approved a supplemental application for HUMALOG MIX75/25 (insulin lispro) from Eli Lilly and Company.

• FDA approval · 2023-07-10
  FDA Approved: XULTOPHY 100/3.6 — Supplemental Application (Novo Nordisk)

  The FDA approved a supplemental application for Xultophy 100/3.6, a fixed-ratio combination of insulin degludec and liraglutide, by Novo Nor…

• FDA approval · 2023-07-05
  FDA Approved: INVOKAMET — Supplemental Application (Janssen Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for INVOKAMET, Janssen’s fixed-dose combination of canagliflozin and metformin hydrochloride.

• FDA approval · 2023-07-05
  FDA Approved: INVOKANA — Supplemental Application (Janssen Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for INVOKANA (canagliflozin) submitted by Janssen Pharmaceuticals, Inc., resulting in a labeling…

• FDA approval · 2023-07-05
  FDA Approved: INVOKAMET XR — Supplemental Application (Janssen Pharmaceuticals, Inc.)

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