Type 1 Diabetes Mellitus

• 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 · 2022-08-16
  FDA Approved: TOUJEO — Supplemental Application (Sanofi-Aventis U.S. LLC)

  The FDA approved a supplemental application for TOUJEO (insulin glargine) from Sanofi-Aventis U.S. LLC, resulting in updated labeling for th…

• FDA approval · 2022-07-01
  FDA Approved: TRESIBA — Supplemental Application (Novo Nordisk)

  FDA approved a supplemental application for TRESIBA (insulin degludec) by Novo Nordisk.

• FDA approval · 2022-06-07
  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, authorizing changes to the …

• FDA approval · 2021-12-17
  FDA Approved: REZVOGLAR KWIKPEN — Original Application (Eli Lilly and Company)

  The FDA approved Rezvoglar KwikPen (insulin glargine-AGLR) from Eli Lilly as an original application, providing a long-acting insulin option…

• Want full summaries, importance scores, and drug timelines? Upgrade to Plus or Pro.
• FDA approval · 2021-10-22
  FDA Approved: NOVOLOG — Supplemental Application (Novo Nordisk)

  The FDA approved a supplemental application for NovoLog (insulin aspart) from Novo Nordisk. The action updates/expands the drug's approved l…

• FDA approval · 2021-08-13
  FDA Approved: LYUMJEV — Supplemental Application (Eli Lilly and Company)

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

• FDA approval · 2021-07-28
  FDA Approved: INSULIN GLARGINE — Original Application (Biocon Biologics Inc.)

  FDA approved Biocon Biologics Inc.'s insulin glargine biosimilar under an Original Application, expanding access to insulin glargine therapy…

• FDA approval · 2021-07-20
  FDA Approved: BASAGLAR KWIKPEN — Supplemental Application (Eli Lilly and Company)

  FDA approved a supplemental application for BASAGLAR KWIKPEN (insulin glargine) from Eli Lilly and Company. The submission status indicates …

• FDA approval · 2021-03-23
  FDA Approved: NOVOLOG — Supplemental Application (Novo Nordisk)

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

• FDA approval · 2020-06-15
  FDA Approved: LYUMJEV — Original Application (Eli Lilly and Company)

  FDA approves LYUMJEV as an original Biologics License Application from Eli Lilly for glycemic control in people with diabetes mellitus, mark…

• FDA approval · 2019-12-27
  FDA Approved: LEVEMIR — Supplemental Application (Novo Nordisk)

  FDA approved a supplemental application for LEVEMIR (insulin detemir) submitted by Novo Nordisk.

• FDA approval · 2019-12-19
  FDA Approved: FIASP — Supplemental Application (Novo Nordisk)

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

• FDA approval · 2019-11-26
  FDA Approved: TOUJEO — Supplemental Application (Sanofi-Aventis U.S. LLC)

  FDA approved a supplemental application for TOUJEO (insulin glargine) from Sanofi-Aventis U.S. LLC.

• FDA approval · 2019-11-15
  FDA Approved: HUMULIN 70/30 — Supplemental Application (Eli Lilly and Company)

  The FDA approved a supplemental application for HUMULIN 70/30 (insulin human) submitted by Eli Lilly and Company.

• FDA approval · 2019-11-15
  FDA Approved: HUMULIN N — Supplemental Application (Eli Lilly and Company)

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

• FDA approval · 2019-11-15
  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 · 2019-11-15
  FDA Approved: HUMALOG MIX50/50 KWIKPEN — Supplemental Application (Eli Lilly and Company)

  FDA approved a supplemental application for HUMALOG MIX50/50 KWIKPEN (insulin lispro) from Eli Lilly.

• FDA approval · 2019-11-15
  FDA Approved: NOVOLIN N — Supplemental Application (Novo Nordisk)

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

• FDA approval · 2019-11-15
  FDA Approved: HUMALOG KWIKPEN — Supplemental Application (Eli Lilly and Company)

  The FDA approved a supplemental application for Humalog KwikPen (insulin lispro) from Eli Lilly and Company.

• FDA approval · 2019-11-15
  FDA Approved: BASAGLAR KWIKPEN — Supplemental Application (Eli Lilly and Company)

  The FDA approved a supplemental application for BASAGLAR KWIKPEN (insulin glargine) from Eli Lilly and Company.

• FDA approval · 2019-11-15
  FDA Approved: FIASP — Supplemental Application (Novo Nordisk)

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

• FDA approval · 2019-11-15
  FDA Approved: LEVEMIR — Supplemental Application (Novo Nordisk)

  The FDA approved a supplemental application for LEVEMIR (insulin detemir) by Novo Nordisk, resulting in updated labeling for the product.

• FDA approval · 2019-11-15
  FDA Approved: INSULIN LISPRO — Supplemental Application (Eli Lilly and Company)

  The FDA approved a supplemental application for insulin lispro from Eli Lilly, updating/expanding its approved use.

• FDA approval · 2019-11-15
  FDA Approved: INSULIN ASPART PROTAMINE AND INSULIN ASPART MIX 70/30 — Supplemental Application (Novo Nordisk Pharma, Inc.)

  FDA approved a supplemental application for Insulin Aspart Protamine and Insulin Aspart Mix 70/30 from Novo Nordisk Pharma, Inc.