Type 1 Diabetes Mellitus

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

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

• FDA approval · 2019-11-15
  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.

• FDA approval · 2019-11-15
  FDA Approved: ADMELOG — Supplemental Application (Sanofi-Aventis U.S. LLC)

  The FDA approved a supplemental application for ADMELOG (insulin lispro) submitted by Sanofi-Aventis U.S. LLC.

• FDA approval · 2019-10-21
  FDA Approved: FIASP — Supplemental Application (Novo Nordisk)

  FDA approved a supplemental application for FIASP (insulin aspart injection) submitted by Novo Nordisk, updating the labeling.

• FDA approval · 2019-08-22
  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.

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• FDA approval · 2019-08-13
  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 · 2019-06-20
  FDA Approved: MYXREDLIN — Original Application (Baxter Healthcare Corporation)

  FDA approved MYXREDLIN (insulin human) from Baxter Healthcare Corporation through an original application for use in the treatment of diabet…

• FDA approval · 2019-05-09
  FDA Approved: LANTUS SOLOSTAR — Supplemental Application (sanofi-aventis U.S. LLC)

  FDA approved a supplemental application for LANTUS SOLOSTAR (insulin glargine) from Sanofi-aventis U.S. LLC.

• EMA approval · 2019-03-01
  New add-on treatment to insulin for treatment of certain patients with type 1 diabetes

  EMA announces a new add-on treatment to insulin for certain patients with type 1 diabetes, expanding therapeutic options.

• EMA approval · 2019-02-01
  First oral add-on treatment to insulin for treatment of certain patients with type 1 diabetes

  The EMA announced approval of the first oral add-on treatment to insulin for certain patients with type 1 diabetes, representing a new thera…

• FDA approval · 2018-12-20
  FDA Approved: APIDRA — Supplemental Application (sanofi-aventis U.S. LLC)

  The FDA approved a supplemental application for APIDRA (insulin glulisine) submitted by Sanofi-Aventis U.S. LLC.

• FDA approval · 2018-12-11
  FDA Approved: INSULIN LISPRO — Supplemental Application (Eli Lilly and Company)

  The FDA approved a supplemental Biologics License Application for insulin lispro from Eli Lilly, authorizing changes to the product's labeli…

• FDA approval · 2018-11-29
  FDA Approved: LANTUS SOLOSTAR — Supplemental Application (sanofi-aventis U.S. LLC)

  The FDA approved a supplemental application for LANTUS SOLOSTAR (insulin glargine) submitted by sanofi-aventis U.S. LLC.

• FDA approval · 2018-11-06
  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 · 2018-11-01
  FDA Approved: INSULIN LISPRO — Supplemental Application (Eli Lilly and Company)

  The FDA approved a supplemental application for INSULIN LISPRO submitted by Eli Lilly and Company.

• FDA approval · 2018-10-25
  FDA Approved: TOUJEO — Supplemental Application (Sanofi-Aventis U.S. LLC)

  FDA approved a supplemental application for Toujeo (insulin glargine) filed by Sanofi-Aventis U.S. LLC.

• FDA approval · 2018-10-25
  FDA Approved: AFREZZA — Supplemental Application (Mannkind Corporation)

  FDA approves a supplemental application for AFREZZA (insulin human) from MannKind Corporation.

• FDA approval · 2018-10-19
  FDA Approved: ADMELOG — Supplemental Application (Sanofi-Aventis U.S. LLC)

  The FDA approved a supplemental application for ADMELOG (insulin lispro) from Sanofi-Aventis U.S. LLC.

• FDA approval · 2018-09-26
  FDA Approved: HUMALOG MIX75/25 — Supplemental Application (Eli Lilly and Company)

  The FDA approved a supplemental application for Humalog Mix75/25 (insulin lispro) filed by Eli Lilly and Company. The action supplements the…

• FDA approval · 2018-09-26
  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.

• FDA approval · 2018-09-05
  FDA Approved: BASAGLAR KWIKPEN — Supplemental Application (Eli Lilly and Company)

  FDA supplemental application approval for BASAGLAR KWIKPEN (insulin glargine) filed by Eli Lilly and Company.

• FDA approval · 2018-09-04
  FDA Approved: FIASP — Supplemental Application (Novo Nordisk)

  The FDA approved a supplemental application for FIASP (insulin aspart injection) from Novo Nordisk, authorizing changes to its labeling.

• FDA approval · 2018-08-09
  FDA Approved: TRESIBA — Supplemental Application (Novo Nordisk)

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

• FDA approval · 2018-07-22
  FDA Approved: FIASP — Supplemental Application (Novo Nordisk)

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

• FDA approval · 2018-06-01
  FDA Approved: NOVOLIN N — Supplemental Application (Novo Nordisk)

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