Type 2 Diabetes Mellitus

• FDA approval · 2020-01-24
  FDA Approved: SYNJARDY XR — Supplemental Application (Boehringer Ingelheim Pharmaceuticals, Inc.)

  FDA approved a supplemental application for SYNJARDY XR (empagliflozin/metformin hydrochloride) from Boehringer Ingelheim Pharmaceuticals, I…

• FDA approval · 2020-01-24
  FDA Approved: STEGLATRO — Supplemental Application (Merck Sharp & Dohme LLC)

  The FDA approved a supplemental application for STEGLATRO (ertugliflozin) filed by Merck Sharp & Dohme LLC, resulting in changes to the drug…

• FDA approval · 2020-01-24
  FDA Approved: SEGLUROMET — Supplemental Application (Merck Sharp & Dohme LLC)

  The FDA approved a supplemental application for Segluromet (ertugliflozin and metformin hydrochloride) from Merck Sharp & Dohme LLC.

• FDA approval · 2020-01-16
  FDA Approved: OZEMPIC — Supplemental Application (Novo Nordisk)

  FDA approved a supplemental application for Ozempic (semaglutide) by Novo Nordisk.

• FDA approval · 2020-01-16
  FDA Approved: OZEMPIC — Supplemental Application (Novo Nordisk)

  The FDA approved a supplemental application for Ozempic to include an oral semaglutide formulation, expanding the product's delivery options…

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• 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 · 2019-12-20
  FDA Approved: GLIPIZIDE — Supplemental Application (ANI Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for glipizide from ANI Pharmaceuticals, Inc., authorizing changes to an already approved product…

• 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 · 2019-12-13
  FDA Approved: BROMOCRIPTINE MESYLATE — Supplemental Application (ANI Pharmaceuticals, Inc.)

  FDA approved a Supplemental Application for Bromocriptine Mesylate by ANI Pharmaceuticals, Inc. The provided excerpt does not specify a new …

• FDA approval · 2019-11-27
  FDA Approved: OZEMPIC — Supplemental Application (Novo Nordisk)

  The FDA approved a supplemental application for OZEMPIC (semaglutide) from Novo Nordisk. The approval updates the drug's labeling or indicat…

• 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 · 2019-11-25
  FDA Approved: METFORMIN HYDROCHLORIDE — Original Application (GLENMARK PHARMACEUTICALS INC., USA)

  FDA approved Metformin hydrochloride from Glenmark as an original generic application.

• 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: SOLIQUA 100/33 — Supplemental Application (Sanofi-Aventis U.S. LLC)

  FDA approved a supplemental application for SOLIQUA 100/33 (insulin glargine and lixisenatide) from Sanofi-Aventis U.S. LLC.

• 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.

• 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.