Type 2 Diabetes Mellitus

• FDA approval · 2014-09-18
  FDA Approved: TRULICITY — Original Application (Eli Lilly and Company)

  The FDA approved the original application for TRULICITY (dulaglutide) from Eli Lilly and Company, authorizing its marketing for adults with …

• FDA approval · 2014-09-12
  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 · 2014-09-12
  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 · 2014-09-12
  FDA Approved: INSULIN LISPRO — Supplemental Application (Eli Lilly and Company)

  FDA approved a supplemental application for insulin lispro from Eli Lilly and Company, with the submission involving a diluent component.

• FDA approval · 2014-09-05
  FDA Approved: LANTUS SOLOSTAR — Supplemental Application (sanofi-aventis U.S. LLC)

  FDA approves a supplemental application for LANTUS SOLOSTAR (insulin glargine) by Sanofi-U.S. LLC.

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• FDA approval · 2014-09-04
  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 mix 70/30) from Novo Nordi…

• FDA approval · 2014-08-29
  FDA Approved: RIOMET — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  The FDA approved a supplemental application for RIOMET (metformin hydrochloride) from Sun Pharmaceutical Industries, Inc.

• FDA approval · 2014-08-28
  FDA Approved: METFORMIN HYDROCHLORIDE — Original Application (Zydus Lifesciences Limited)

  FDA approved the Original Application for Metformin Hydrochloride by Zydus Lifesciences Limited, a generic version of metformin. It is used …

• FDA approval · 2014-08-25
  FDA Approved: GLYBURIDE — Supplemental Application (TEVA Pharmaceuticals USA Inc)

  FDA approves a supplemental application for glyburide by Teva Pharmaceuticals USA Inc.

• FDA approval · 2014-08-21
  FDA Approved: KAZANO — Supplemental Application (Takeda Pharmaceuticals America, Inc.)

  FDA approves a supplemental application for KAZANO (alogliptin and metformin hydrochloride) from Takeda Pharmaceuticals America, Inc. This n…

• FDA approval · 2014-08-16
  FDA Approved: ACTOPLUS MET — Supplemental Application (Takeda Pharmaceuticals America, Inc.)

  FDA approved a supplemental application for ACTOPLUS MET, a fixed-dose combination of pioglitazone and metformin HCl, manufactured by Takeda…

• FDA approval · 2014-08-08
  FDA Approved: INVOKAMET — Original Application (Janssen Pharmaceuticals, Inc.)

  FDA approved INVOKAMET, a fixed-dose combination of canagliflozin and metformin hydrochloride, through Janssen's original NDA.

• FDA approval · 2014-08-01
  FDA Approved: JARDIANCE — Original Application (Boehringer Ingelheim Pharmaceuticals, Inc.)

  FDA approves JARDIANCE (empagliflozin) as an original application for the treatment of type 2 diabetes mellitus.

• FDA approval · 2014-08-01
  FDA Approved: GLIMEPIRIDE — Supplemental Application (Accord Healthcare Inc)

  FDA approved a supplemental application for glimepiride from Accord Healthcare Inc, enabling the generic product to continue to be marketed.

• FDA approval · 2014-07-31
  FDA Approved: LIRAGLUTIDE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved Teva's supplemental application for liraglutide (NDA 022341), updating labeling and/or indications for the product.

• FDA approval · 2014-07-30
  FDA Approved: JENTADUETO — Supplemental Application (Boehringer Ingelheim Pharmaceuticals, Inc.)

  FDA approved a supplemental application for JENTADUETO, a fixed-dose combination of linagliptin and metformin hydrochloride, by Boehringer I…

• FDA approval · 2014-06-27
  FDA Approved: AFREZZA — Original Application (Mannkind Corporation)

  FDA approved AFREZZA (insulin human) from Mannkind Corporation as an original application, introducing an inhaled insulin product for adults…

• FDA approval · 2014-06-20
  FDA Approved: HUMULIN R — Supplemental Application (Eli Lilly and Company)

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

• FDA approval · 2014-06-17
  FDA Approved: METFORMIN HYDROCHLORIDE — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA approved a supplemental application for METFORMIN HYDROCHLORIDE from Mylan Pharmaceuticals Inc. (ANDA 075973), adding or confirming regu…

• FDA approval · 2014-06-10
  FDA Approved: HUMULIN N — Supplemental Application (Eli Lilly and Company)

  FDA approves a supplemental application for Humulin N (insulin human) submitted by Eli Lilly and Company. This action is an approval of a su…

• FDA approval · 2014-06-05
  FDA Approved: INVOKANA — Supplemental Application (Janssen Pharmaceuticals, Inc.)

  The FDA approved Janssen's supplemental application for INVOKANA (canagliflozin), resulting in updated labeling for the product.

• FDA approval · 2014-06-04
  FDA Approved: BYETTA — Supplemental Application (AstraZeneca Pharmaceuticals LP)

  FDA approved a supplemental application for BYETTA (exenatide) from AstraZeneca Pharmaceuticals LP.

• FDA approval · 2014-06-04
  FDA Approved: INSULIN LISPRO — Supplemental Application (Eli Lilly and Company)

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

• FDA approval · 2014-06-04
  FDA Approved: HUMALOG MIX75/25 — Supplemental Application (Eli Lilly and Company)

  The FDA approved a supplemental application for Humalog Mix75/25 (insulin lispro) submitted by Eli Lilly and Company, likely updating labeli…

• FDA approval · 2014-06-04
  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), expanding the availability of the 50/50 insulin l…