Type 2 Diabetes Mellitus

• FDA approval · 2015-08-26
  FDA Approved: SYNJARDY — Original Application (Boehringer Ingelheim Pharmaceuticals, Inc.)

  The FDA approved SYNJARDY (empagliflozin and metformin hydrochloride) as an Original Application for the treatment of type 2 diabetes mellit…

• FDA approval · 2015-08-18
  FDA Approved: NATEGLINIDE — Supplemental Application (Dr. Reddy's Laboratories Limited)

  FDA approved a supplemental application for Dr. Reddy's Laboratories Limited for nateglinide (generic) under an ANDA.

• FDA approval · 2015-08-17
  FDA Approved: GLIPIZIDE AND METFORMIN HYDROCHLORIDE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved a supplemental application for GLIPIZIDE AND METFORMIN HYDROCHLORIDE (Teva), a fixed-dose combination product. The action perta…

• 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 · 2015-07-28
  FDA Approved: TRADJENTA — Supplemental Application (Boehringer Ingelheim Pharmaceuticals, Inc.)

  FDA approved a supplemental application for Tradjenta (linagliptin) submitted by Boehringer Ingelheim Pharmaceuticals, Inc.

• Want full summaries, importance scores, and drug timelines? Upgrade to Plus or Pro.
• FDA approval · 2015-07-27
  FDA Approved: TRULICITY — Supplemental Application (Eli Lilly and Company)

  The FDA approved a supplemental application for TRULICITY (dulaglutide) from Eli Lilly and Company. The approval updates the product labelin…

• FDA approval · 2015-07-21
  FDA Approved: PIOGLITAZONE HYDROCHLORIDE — Supplemental Application (Aurobindo Pharma Limited)

  The FDA approved a supplemental application for pioglitazone hydrochloride (pioglitazone) from Aurobindo Pharma Limited.

• FDA approval · 2015-07-20
  FDA Approved: TRADJENTA — Supplemental Application (Boehringer Ingelheim Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for TRADJENTA (linagliptin) from Boehringer Ingelheim Pharmaceuticals, Inc.

• FDA approval · 2015-07-20
  FDA Approved: ALOGLIPTIN — Supplemental Application (Padagis Israel Pharmaceuticals Ltd)

  FDA approved a supplemental application for alogliptin from Padagis Israel Pharmaceuticals Ltd, indicating an update related to the product'…

• 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 · 2015-06-30
  FDA Approved: GLIMEPIRIDE — Supplemental Application (Carlsbad Technology, Inc.)

  FDA approved a supplemental application for the generic antidiabetic drug glimepiride submitted by Carlsbad Technology, Inc.

• FDA approval · 2015-06-26
  FDA Approved: JARDIANCE — Supplemental Application (Boehringer Ingelheim Pharmaceuticals, Inc.)

  FDA approved a supplemental application for Jardiance (empagliflozin) by Boehringer Ingelheim Pharmaceuticals, Inc.

• 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: JANUMET — Supplemental Application (Merck Sharp & Dohme LLC)

  FDA approves a supplemental application for JANUMET (sitagliptin/metformin hydrochloride) from Merck Sharp & Dohme LLC, updating the labelin…

• 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 · 2015-06-08
  FDA Approved: INVOKAMET — Supplemental Application (Janssen Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for INVOKAMET, the fixed-dose combination of canagliflozin and metformin hydrochloride, submitte…

• FDA approval · 2015-06-02
  FDA Approved: GLIPIZIDE AND METFORMIN HYDROCHLORIDE — Supplemental Application (Zydus Pharmaceuticals USA Inc.)

  The FDA approved a supplemental application for Glipizide and Metformin Hydrochloride from Zydus Pharmaceuticals USA Inc., confirming the co…

• 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 · 2015-04-27
  FDA Approved: JANUVIA — Supplemental Application (Merck Sharp & Dohme LLC)

  The FDA has approved a supplemental application for Januvia (sitagliptin) submitted by Merck Sharp & Dohme LLC.

• FDA approval · 2015-04-27
  FDA Approved: JANUMET XR — Supplemental Application (Merck Sharp & Dohme LLC)

  The FDA approved a supplemental application for JANUMET XR (sitagliptin and metformin hydrochloride) by Merck Sharp & Dohme LLC.

• FDA approval · 2015-04-24
  FDA Approved: GLIMEPIRIDE — Supplemental Application (Dr. Reddy's Laboratories Limited)

  The FDA approved a supplemental application for a generic glimepiride product from Dr. Reddy's Laboratories Limited.

• 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.