Type 1 Diabetes Mellitus

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

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

• FDA approval · 2018-06-01
  FDA Approved: NOVOLIN 70/30 — Supplemental Application (Novo Nordisk)

  FDA approved a supplemental application for Novo Nordisk's Novolin 70/30 (human insulin), updating the product's regulatory status.

• FDA approval · 2018-05-25
  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 · 2018-04-24
  FDA Approved: AFREZZA — Supplemental Application (Mannkind Corporation)

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

• FDA approval · 2018-03-26
  FDA Approved: TOUJEO — Supplemental Application (Sanofi-Aventis U.S. LLC)

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

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• FDA approval · 2018-03-26
  FDA Approved: TRESIBA — Supplemental Application (Novo Nordisk)

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

• FDA approval · 2018-03-06
  FDA Approved: FIASP — Supplemental Application (Novo Nordisk)

  FDA approved a supplemental application for FIASP (insulin aspart injection) by Novo Nordisk. The approval results in an updated labeling fo…

• FDA approval · 2017-12-11
  FDA Approved: ADMELOG — Original Application (Sanofi-Aventis U.S. LLC)

  FDA approves ADMELOG (insulin lispro) from Sanofi-Aventis U.S. LLC under a Biologics License Application.

• FDA approval · 2017-09-29
  FDA Approved: AFREZZA — Supplemental Application (Mannkind Corporation)

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

• FDA approval · 2017-09-29
  FDA Approved: FIASP — Original Application (Novo Nordisk)

  FDA approves the original application for FIASP (insulin aspart injection) by Novo Nordisk.

• FDA approval · 2017-06-06
  FDA Approved: INSULIN LISPRO — Supplemental Application (Eli Lilly and Company)

  FDA approved a supplemental application for Eli Lilly’s insulin lispro, including a diluent component, updating the product’s labeling/admin…

• FDA approval · 2017-05-08
  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 (insulin aspart protamine and insulin aspa…

• FDA approval · 2017-03-16
  FDA Approved: NOVOLOG — Supplemental Application (Novo Nordisk)

  The FDA approved a supplemental application for NovoLog (insulin aspart) submitted by Novo Nordisk. The entry indicates the supplement has b…

• FDA approval · 2017-01-06
  FDA Approved: INSULIN LISPRO — Supplemental Application (Eli Lilly and Company)

  The FDA approved a supplemental application for insulin lispro from Eli Lilly and Company.

• FDA approval · 2017-01-06
  FDA Approved: HUMULIN N — Supplemental Application (Eli Lilly and Company)

  The FDA approved a supplemental application for Humulin N (insulin human) from Eli Lilly, updating the product's labeling and approval detai…

• FDA approval · 2017-01-06
  FDA Approved: HUMALOG MIX75/25 — Supplemental Application (Eli Lilly and Company)

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

• FDA approval · 2017-01-06
  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 and Company.

• FDA approval · 2017-01-06
  FDA Approved: HUMALOG KWIKPEN — Supplemental Application (Eli Lilly and Company)

  FDA approved a supplemental application for Humalog KwikPen (insulin lispro) by Eli Lilly.

• FDA approval · 2016-12-16
  FDA Approved: TRESIBA — Supplemental Application (Novo Nordisk)

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

• FDA approval · 2016-11-23
  FDA Approved: TOUJEO — Supplemental Application (Sanofi-Aventis U.S. LLC)

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

• FDA approval · 2016-10-07
  FDA Approved: NOVOLOG — Supplemental Application (Novo Nordisk)

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

• FDA approval · 2016-08-05
  FDA Approved: HUMALOG KWIKPEN — Supplemental Application (Eli Lilly and Company)

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

• FDA approval · 2016-07-08
  FDA Approved: TRESIBA — Supplemental Application (Novo Nordisk)

  The FDA approved a supplemental application for Tresiba (insulin degludec) from Novo Nordisk.

• FDA approval · 2016-06-17
  FDA Approved: BASAGLAR KWIKPEN — Supplemental Application (Eli Lilly and Company)

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

• FDA approval · 2016-06-01
  FDA Approved: BASAGLAR KWIKPEN — Supplemental Application (Eli Lilly and Company)

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