Diabetes Mellitus

• EMA approval · 2023-08-29
  EMA Authorised: NovoMix (insulin aspart) — Novo Nordisk A/S

  NovoMix (insulin aspart) by Novo Nordisk A/S has been authorised for use in the European market for diabetes mellitus.

• 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 MIX75/25 — Supplemental Application (Eli Lilly and Company)

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

• EMA approval · 2023-07-06
  EMA Authorised: Truvelog Mix 30 (insulin aspart) — Sanofi Winthrop Industrie

  EMA has authorized Truvelog Mix 30 (insulin aspart) for the treatment of diabetes mellitus in the European Union.

• FDA approval · 2023-06-21
  FDA Approved: FIASP — Supplemental Application (Novo Nordisk)

  FDA approved a supplemental application for FIASP (insulin aspart injection) from Novo Nordisk.

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• 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 · 2022-11-23
  FDA Approved: NOVOLIN N — Supplemental Application (Novo Nordisk)

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

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

  The FDA granted a supplemental approval for Novo Nordisk's NOVOLIN R (human insulin), as part of a supplemental application submitted by Nov…

• FDA approval · 2022-07-14
  FDA Approved: GLUCAGON — Supplemental Application (Fresenius Kabi USA, LLC)

  The FDA approved a supplemental application for Glucagon submitted by Fresenius Kabi USA, LLC.

• FDA approval · 2022-06-27
  FDA Approved: HUMULIN N — Supplemental Application (Eli Lilly and Company)

  FDA approved a supplemental application for HUMULIN N (insulin human) filed by Eli Lilly and Company.

• FDA approval · 2022-06-27
  FDA Approved: HUMULIN 70/30 — Supplemental Application (Eli Lilly and Company)

  The FDA approved a supplemental application for Humulin 70/30 (insulin human) from Eli Lilly and Company.

• FDA approval · 2022-06-27
  FDA Approved: HUMULIN R — Supplemental Application (Eli Lilly and Company)

  FDA approved a supplemental application for Humulin R (insulin human) by Eli Lilly and Company.

• EMA approval · 2021-09-23
  EMA Authorised: Fiasp (insulin aspart) — Novo Nordisk A/S

  European Medicines Agency information indicates that Fiasp (insulin aspart) by Novo Nordisk A/S has been authorised for Diabetes Mellitus.

• FDA approval · 2021-08-20
  FDA Approved: GVOKE HYPOPEN 0.5 MG AUTO-INJECTOR — Supplemental Application (Xeris Pharmaceuticals, Inc.)

  FDA approves a supplemental application for GVOKE HYPOPEN 0.5 MG AUTO-INJECTOR, a glucagon injection solution, expanding its device format f…

• FDA approval · 2021-07-29
  FDA Approved: GLUCAGON — Supplemental Application (Fresenius Kabi USA, LLC)

  The FDA approved a supplemental application for the glucagon product from Fresenius Kabi USA, LLC.

• EMA approval · 2021-07-13
  EMA Authorised: Levemir (Insulin detemir) — Novo Nordisk A/S

  EMA Authorised Levemir (insulin detemir) by Novo Nordisk A/S for diabetes mellitus.

• FDA approval · 2021-04-28
  FDA Approved: INSULIN ASPART PROTAMINE AND INSULIN ASPART MIX 70/30 — Supplemental Application (Novo Nordisk Pharma, Inc.)

  The FDA approved a supplemental application for Novo Nordisk's insulin aspart protamine and insulin aspart mix 70/30.

• FDA approval · 2021-03-22
  FDA Approved: ZEGALOGUE — Original Application (Novo Nordisk)

  The FDA approved ZEGALOGUE (dasiglucagon) from Novo Nordisk in an Original Application for the treatment of severe hypoglycemia in adults an…

• FDA approval · 2020-12-28
  FDA Approved: GLUCAGON — Original Application (Amphastar Pharmaceuticals, Inc.)

  The FDA approved Amphastar Pharmaceuticals' original application for a generic glucagon product to treat severe hypoglycemia in patients wit…

• EMA approval · 2020-11-23
  EMA Authorised: Insulatard (Insulin human) — Novo Nordisk A/S

  Authorised status for Insulatard (insulin human) from Novo Nordisk A/S for diabetes mellitus in the European market.

• EMA approval · 2020-10-27
  EMA Authorised: Protaphane (Insulin human) — Novo Nordisk A/S

  Protaphane (insulin human) by Novo Nordisk A/S has been authorised for use in the European Union for diabetes mellitus.

• FDA approval · 2020-10-27
  FDA Approved: BAQSIMI — Supplemental Application (Amphastar Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for BAQSIMI (glucagon nasal powder) from Amphastar Pharmaceuticals, broadening regulatory approv…

• EMA approval · 2020-10-21
  EMA Authorised: Actrapid (human insulin) — Novo Nordisk A/S

  Actrapid (human insulin) by Novo Nordisk A/S has been authorised by the EMA for diabetes mellitus.

• FDA approval · 2020-06-04
  FDA Approved: MYXREDLIN — Supplemental Application (Baxter Healthcare Corporation)

  FDA approved a supplemental application for MYXREDLIN (insulin human) from Baxter Healthcare Corporation, authorizing changes to the product…

• FDA approval · 2020-04-07
  FDA Approved: GVOKE HYPOPEN 0.5 MG AUTO-INJECTOR — Supplemental Application (Xeris Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for GVOKE HYPOPEN 0.5 MG AUTO-INJECTOR (glucagon injection, solution) from Xeris Pharmaceuticals…