Type 2 Diabetes Mellitus

• FDA approval · 2018-10-26
  FDA Approved: SYNJARDY — Supplemental Application (Boehringer Ingelheim Pharmaceuticals, Inc.)

  FDA approved a supplemental application for Synjardy (empagliflozin and metformin hydrochloride) submitted by Boehringer Ingelheim Pharmaceu…

• FDA approval · 2018-10-26
  FDA Approved: SYNJARDY XR — Supplemental Application (Boehringer Ingelheim Pharmaceuticals, Inc.)

  FDA approved a supplemental application for SYNJARDY XR (empagliflozin and metformin hydrochloride) from Boehringer Ingelheim Pharmaceutical…

• FDA approval · 2018-10-25
  FDA Approved: TOUJEO — Supplemental Application (Sanofi-Aventis U.S. LLC)

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

• FDA approval · 2018-10-25
  FDA Approved: AFREZZA — Supplemental Application (Mannkind Corporation)

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

• FDA approval · 2018-10-22
  FDA Approved: METFORMIN HYDROCHLORIDE — Original Application (Ascend Laboratories, LLC)

  FDA approved a generic metformin hydrochloride product under an Original Application (ANDA206145) from Ascend Laboratories, LLC.

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• FDA approval · 2018-10-19
  FDA Approved: ADMELOG — Supplemental Application (Sanofi-Aventis U.S. LLC)

  The FDA approved a supplemental application for ADMELOG (insulin lispro) from Sanofi-Aventis U.S. LLC.

• FDA approval · 2018-10-05
  FDA Approved: COLESEVELAM HYDROCHLORIDE — Original Application (Dr.Reddys Laboratories Inc)

  FDA approved a generic Colesevelam Hydrochloride (colesevelam hydrochloride) via an Original Application filed by Dr. Reddy's Laboratories I…

• FDA approval · 2018-10-05
  FDA Approved: COLESEVELAM HCL — Original Application (Ascend Laboratories, LLC)

  FDA approved Ascend Laboratories' Colesevelam HCl (generic) under ANDA209038. The drug is a bile acid sequestrant indicated to reduce LDL ch…

• FDA approval · 2018-09-26
  FDA Approved: HUMALOG MIX75/25 — Supplemental Application (Eli Lilly and Company)

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

• FDA approval · 2018-09-26
  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) from Eli Lilly and Company.

• FDA approval · 2018-09-24
  FDA Approved: METFORMIN HYDROCHLORIDE — Original Application (Epic Pharma, LLC)

  FDA approved Epic Pharma, LLC's original application for metformin hydrochloride (generic metformin hydrochloride).

• FDA approval · 2018-09-21
  FDA Approved: TRULICITY — Supplemental Application (Eli Lilly and Company)

  FDA approved a supplemental application for Trulicity (dulaglutide) submitted by Eli Lilly and Company.

• FDA approval · 2018-09-05
  FDA Approved: BASAGLAR KWIKPEN — Supplemental Application (Eli Lilly and Company)

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

• FDA approval · 2018-09-04
  FDA Approved: FIASP — Supplemental Application (Novo Nordisk)

  The FDA approved a supplemental application for FIASP (insulin aspart injection) from Novo Nordisk, authorizing changes to its labeling.

• FDA approval · 2018-08-27
  FDA Approved: METFORMIN HYDROCHLORIDE — Original Application (Laurus Labs Limited)

  FDA approves Laurus Labs Limited's metformin hydrochloride as a generic drug under ANDA 209882.

• FDA approval · 2018-08-10
  FDA Approved: GLUCOTROL XL — Supplemental Application (Roerig)

  FDA approved a supplemental application for GLUCOTROL XL (glipizide) submitted by Roerig. The action concerns the extended-release formulati…

• FDA approval · 2018-08-09
  FDA Approved: TRESIBA — Supplemental Application (Novo Nordisk)

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

• FDA approval · 2018-07-22
  FDA Approved: FIASP — Supplemental Application (Novo Nordisk)

  The FDA approved a supplemental application for FIASP (insulin aspart injection) from Novo Nordisk.

• FDA approval · 2018-07-16
  FDA Approved: GLIPIZIDE — Original Application (Northstar Rx LLC.)

  The FDA approved an original abbreviated new drug application (ANDA) for generic glipizide, manufactured by Northstar Rx LLC.

• FDA approval · 2018-06-29
  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/expands the drug’s …

• FDA approval · 2018-06-18
  FDA Approved: NATEGLINIDE — Original Application (Rising Pharma Holdings, Inc.)

  FDA approved the original application for a generic version of nateglinide, manufactured by Rising Pharma Holdings, Inc.

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

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

• 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.