Type 1 Diabetes Mellitus

• FDA approval · 2016-04-07
  FDA Approved: AFREZZA — Supplemental Application (Mannkind Corporation)

  The FDA approved a supplemental application for AFREZZA (insulin human) from Mannkind Corporation.

• FDA approval · 2016-04-05
  FDA Approved: HUMULIN N — Supplemental Application (Eli Lilly and Company)

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

• FDA approval · 2016-02-16
  FDA Approved: TOUJEO — Supplemental Application (Sanofi-Aventis U.S. LLC)

  The FDA approved a supplemental application for Toujeo (insulin glargine) submitted by Sanofi-Aventis U.S. LLC. The approval pertains to cha…

• FDA approval · 2016-01-08
  FDA Approved: NOVOLIN R — Supplemental Application (Novo Nordisk)

  The FDA approved a supplemental application for NOVOLIN R (human insulin) submitted by Novo Nordisk. The action represents regulatory approv…

• FDA approval · 2016-01-08
  FDA Approved: NOVOLIN N — Supplemental Application (Novo Nordisk)

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

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• FDA approval · 2015-12-16
  FDA Approved: BASAGLAR KWIKPEN — Original Application (Eli Lilly and Company)

  FDA approved BASAGLAR KWIKPEN (insulin glargine) by Eli Lilly in an Original Application as a long-acting insulin for glycemic control in ad…

• FDA approval · 2015-11-25
  FDA Approved: HUMALOG KWIKPEN — Supplemental Application (Eli Lilly and Company)

  FDA approved a supplemental application for HUMALOG KWIKPEN (insulin lispro) submitted by Eli Lilly, resulting in a labeling action for the …

• FDA approval · 2015-10-20
  FDA Approved: HUMULIN N — Supplemental Application (Eli Lilly and Company)

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

• FDA approval · 2015-09-29
  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 · 2015-09-25
  FDA Approved: TRESIBA — Original Application (Novo Nordisk)

  FDA approved the original Biologics License Application for Tresiba (insulin degludec) from Novo Nordisk, establishing a long-acting insulin…

• FDA approval · 2015-09-16
  FDA Approved: AFREZZA — Supplemental Application (Mannkind Corporation)

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

• FDA approval · 2015-09-10
  FDA Approved: INSULIN LISPRO — Supplemental Application (Eli Lilly and Company)

  The FDA has granted a supplemental approval for insulin lispro submitted by Eli Lilly and Company.

• FDA approval · 2015-08-07
  FDA Approved: SYMLINPEN — Supplemental Application (AstraZeneca Pharmaceuticals LP)

  FDA approved a supplemental application for SYMLINPEN (pramlintide acetate) from AstraZeneca.

• FDA approval · 2015-07-17
  FDA Approved: LANTUS SOLOSTAR — Supplemental Application (sanofi-aventis U.S. LLC)

  FDA approved a supplemental application for Lantus SoloStar (insulin glargine) submitted by Sanofi-Aventis U.S. LLC.

• FDA approval · 2015-07-15
  FDA Approved: HUMULIN N — Supplemental Application (Eli Lilly and Company)

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

• FDA approval · 2015-06-24
  FDA Approved: AFREZZA — Supplemental Application (Mannkind Corporation)

  The FDA approved a supplemental application for Afrezza (insulin human) from MannKind Corporation. This approval updates the label/indicatio…

• FDA approval · 2015-06-16
  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. This action indicat…

• FDA approval · 2015-06-12
  FDA Approved: INSULIN LISPRO — Supplemental Application (Eli Lilly and Company)

  FDA approved a supplemental application for insulin lispro from Eli Lilly, resulting in an additional regulatory action for this product.

• FDA approval · 2015-06-11
  FDA Approved: INSULIN LISPRO — Supplemental Application (Eli Lilly and Company)

  The FDA approved a supplemental application for insulin lispro from Eli Lilly (Humalog). This action typically relates to labeling changes o…

• FDA approval · 2015-05-26
  FDA Approved: HUMALOG KWIKPEN — Original Application (Eli Lilly and Company)

  The FDA approved Humalog KwikPen (insulin lispro) from Eli Lilly under an original application, enabling a rapid-acting insulin pen for bloo…

• FDA approval · 2015-04-24
  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 · 2015-04-20
  FDA Approved: AFREZZA — Supplemental Application (Mannkind Corporation)

  The FDA approved a supplemental application for AFREZZA (insulin human) submitted by MannKind Corporation.

• FDA approval · 2015-04-17
  FDA Approved: NOVOLOG — Supplemental Application (Novo Nordisk)

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

• FDA approval · 2015-04-17
  FDA Approved: AFREZZA — Supplemental Application (Mannkind Corporation)

  FDA approved a supplemental application for AFREZZA (insulin human) submitted by MannKind Corporation.

• FDA approval · 2015-03-20
  FDA Approved: SYMLINPEN — Supplemental Application (AstraZeneca Pharmaceuticals LP)

  FDA approved a supplemental application for SYMLINPEN (pramlintide acetate) from AstraZeneca Pharmaceuticals LP.