Type 2 Diabetes Mellitus

• FDA approval · 2012-07-09
  FDA Approved: WELCHOL — Supplemental Application (Cosette Pharmaceuticals, Inc.)

  FDA approved a supplemental application for Welchol (colesevelam hydrochloride) submitted by Cosette Pharmaceuticals, Inc.

• FDA approval · 2012-06-29
  FDA Approved: GLIMEPIRIDE — Original Application (Micro Labs Limited)

  FDA approved the original ANDA for glimepiride manufactured by Micro Labs Limited, a generic drug for type 2 diabetes mellitus to improve gl…

• FDA approval · 2012-06-29
  FDA Approved: GLIMEPIRIDE — Original Application (Rising Pharma Holdings, Inc.)

  FDA approved the original application for glimepiride (Rising Pharma Holdings, Inc.), a generic medication for type 2 diabetes mellitus.

• FDA approval · 2012-06-01
  FDA Approved: GLIMEPIRIDE — Supplemental Application (Accord Healthcare Inc)

  The FDA approved a supplemental application for glimepiride by Accord Healthcare Inc.

• FDA approval · 2012-05-31
  FDA Approved: GLIMEPIRIDE — Supplemental Application (Solco Healthcare U.S., LLC)

  The FDA approved a supplemental application for Solco Healthcare U.S., LLC to market a generic version of glimepiride. Glimepiride is used t…

• Want full summaries, importance scores, and drug timelines? Upgrade to Plus or Pro.
• FDA approval · 2012-05-22
  FDA Approved: TRADJENTA — Supplemental Application (Boehringer Ingelheim Pharmaceuticals, Inc.)

  FDA approved a supplemental application for TRADJENTA (linagliptin) filed by Boehringer Ingelheim Pharmaceuticals, Inc., resulting in update…

• FDA approval · 2012-05-17
  FDA Approved: ACTOS — Supplemental Application (Takeda Pharmaceuticals America, Inc.)

  FDA approved a supplemental application for ACTOS (pioglitazone) submitted by Takeda Pharmaceuticals America, Inc.

• FDA approval · 2012-05-17
  FDA Approved: PIOGLITAZONE AND GLIMEPIRIDE — Supplemental Application (Prasco Laboratories)

  FDA approved a supplemental application for a pioglitazone and glimepiride combination product from Prasco Laboratories.

• FDA approval · 2012-05-17
  FDA Approved: ACTOPLUS MET — Supplemental Application (Takeda Pharmaceuticals America, Inc.)

  The FDA approved a supplemental application for ACTOPLUS MET (pioglitazone and metformin hydrochloride) by Takeda Pharmaceuticals America, I…

• FDA approval · 2012-04-27
  FDA Approved: LEVEMIR — Supplemental Application (Novo Nordisk)

  FDA approved a supplemental application for LEVEMIR (insulin detemir) from Novo Nordisk.

• EMA approval · 2012-04-20
  European Medicines Agency recommends authorisation of novel treatment for type-2 diabetes

  The European Medicines Agency recommends authorisation of a novel treatment for type 2 diabetes, signaling potential new option for manageme…

• FDA approval · 2012-04-17
  FDA Approved: GLIPIZIDE AND METFORMIN HYDROCHLORIDE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved a supplemental application for Teva's glipizide and metformin hydrochloride, a combination medication for type 2 diabetes, indi…

• FDA approval · 2012-03-29
  FDA Approved: LEVEMIR — Supplemental Application (Novo Nordisk)

  The FDA approved a supplemental application for LEVEMIR (insulin detemir) from Novo Nordisk, resulting in changes to its labeling.

• FDA approval · 2012-03-24
  FDA Approved: JANUVIA — Supplemental Application (Merck Sharp & Dohme LLC)

  FDA approved a supplemental application for JANUVIA (sitagliptin) submitted by Merck, resulting in an updated indication/label.

• FDA approval · 2012-03-24
  FDA Approved: JANUMET — Supplemental Application (Merck Sharp & Dohme LLC)

  FDA approves a supplemental application for JANUMET (sitagliptin/metformin hydrochloride) from Merck Sharp & Dohme LLC. The action updates t…

• FDA approval · 2012-03-21
  FDA Approved: HUMULIN 70/30 — Supplemental Application (Eli Lilly and Company)

  FDA approved a supplemental application for HUMULIN 70/30 (insulin human) from Eli Lilly and Company.

• FDA approval · 2012-03-21
  FDA Approved: HUMALOG MIX75/25 — Supplemental Application (Eli Lilly and Company)

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

• FDA approval · 2012-03-21
  FDA Approved: HUMALOG MIX50/50 KWIKPEN — Supplemental Application (Eli Lilly and Company)

  The FDA approved a supplemental application for HUMALOG MIX50/50 KWIKPEN, a premixed insulin lispro product, to be delivered via the KWIKPEN…

• FDA approval · 2012-03-12
  FDA Approved: METFORMIN HCL — Original Application (TIME CAP LABORATORIES, INC)

  FDA approved metformin hydrochloride as an original generic application by Time Cap Laboratories, Inc. for treatment of type 2 diabetes mell…

• FDA approval · 2012-02-27
  FDA Approved: JANUVIA — Supplemental Application (Merck Sharp & Dohme LLC)

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

• FDA approval · 2012-02-09
  FDA Approved: METFORMIN HYDROCHLORIDE — Supplemental Application (Mylan Pharmaceuticals Inc.)

  The FDA approved a supplemental application for METFORMIN HYDROCHLORIDE submitted by Mylan Pharmaceuticals Inc., authorizing an approved mod…

• FDA approval · 2012-02-07
  FDA Approved: ACARBOSE — Original Application (Chartwell RX, LLC)

  The FDA approved Chartwell RX, LLC's original ANDA for acarbose, a generic medication used to help manage blood glucose in type 2 diabetes.

• FDA approval · 2012-02-02
  FDA Approved: JANUMET XR — Original Application (Merck Sharp & Dohme LLC)

  FDA approved JANUMET XR, a new extended-release formulation combining sitagliptin and metformin hydrochloride for type 2 diabetes mellitus.

• FDA approval · 2012-01-30
  FDA Approved: JENTADUETO — Original Application (Boehringer Ingelheim Pharmaceuticals, Inc.)

  FDA approved JENTADUETO (linagliptin and metformin hydrochloride) under an Original Application by Boehringer Ingelheim Pharmaceuticals, Inc…

• FDA approval · 2012-01-26
  FDA Approved: METFORMIN HYDROCHLORIDE — Supplemental Application (Granules Pharmaceuticals Inc.)

  FDA approved a supplemental application for METFORMIN HYDROCHLORIDE by Granules Pharmaceuticals Inc., granting regulatory acceptance for thi…