Type 2 Diabetes Mellitus

• FDA approval · 2012-01-18
  FDA Approved: METFORMIN HYDROCHLORIDE — Original Application (Ascend Laboratories, LLC)

  The FDA approved Ascend Laboratories' metformin hydrochloride product under an Original Application (ANDA201991), providing a generic option…

• FDA approval · 2012-01-03
  FDA Approved: WELCHOL — Supplemental Application (Cosette Pharmaceuticals, Inc.)

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

• FDA approval · 2012-01-03
  FDA Approved: SYMLINPEN — Supplemental Application (AstraZeneca Pharmaceuticals LP)

  The FDA approved a supplemental application for SYMLINPEN (pramlintide acetate) from AstraZeneca Pharmaceuticals LP.

• FDA approval · 2012-01-03
  FDA Approved: WELCHOL — Supplemental Application (Cosette Pharmaceuticals, Inc.)

  FDA approved a supplemental application for Welchol (colesevelam hydrochloride) from Cosette Pharmaceuticals, Inc., indicating a labeling or…

• FDA approval · 2011-10-30
  FDA Approved: INSULIN LISPRO — Supplemental Application (Eli Lilly and Company)

  The FDA approved a supplemental application for insulin lispro from Eli Lilly, including the diluent, indicating regulatory approval of chan…

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• FDA approval · 2011-10-30
  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 · 2011-10-30
  FDA Approved: HUMALOG MIX50/50 KWIKPEN — Supplemental Application (Eli Lilly and Company)

  FDA approved Eli Lilly's supplemental application for Humalog Mix50/50 KwikPen (insulin lispro). The approval pertains to the Humalog Mix50/…

• FDA approval · 2011-10-30
  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 · 2011-10-19
  FDA Approved: BYETTA — Supplemental Application (AstraZeneca Pharmaceuticals LP)

  The FDA approved a supplemental application for BYETTA (exenatide) submitted by AstraZeneca Pharmaceuticals LP.

• FDA approval · 2011-08-25
  FDA Approved: GLYBURIDE — Supplemental Application (Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.)

  FDA approved Heritage Pharmaceuticals' supplemental application for glyburide (GLYBURIDE) from Heritage Pharmaceuticals Inc. d/b/a Avet Phar…

• FDA approval · 2011-08-18
  FDA Approved: GLYBURIDE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  The FDA approved Teva Pharmaceuticals USA, Inc.'s supplemental application for the generic drug glyburide under ANDA074686.

• FDA approval · 2011-08-05
  FDA Approved: BYETTA — Supplemental Application (AstraZeneca Pharmaceuticals LP)

  FDA approved a supplemental application for BYETTA (exenatide) from AstraZeneca Pharmaceuticals LP. The approval concerns a supplemental sub…

• FDA approval · 2011-08-04
  FDA Approved: PIOGLITAZONE AND GLIMEPIRIDE — Supplemental Application (Prasco Laboratories)

  The FDA approved a supplemental application for Pioglitazone and Glimepiride from Prasco Laboratories.

• FDA approval · 2011-08-04
  FDA Approved: ACTOPLUS MET — Supplemental Application (Takeda Pharmaceuticals America, Inc.)

  FDA approved a supplemental application for Actoplus Met (pioglitazone and metformin hydrochloride) from Takeda Pharmaceuticals America, Inc…

• FDA approval · 2011-07-27
  FDA Approved: ACARBOSE — Original Application (Strides Pharma Science Limited)

  The FDA approved Strides Pharma Science Limited's generic acarbose (ACARBOSE) under an Original Application (ANDA). This approval enables ma…

• FDA approval · 2011-06-10
  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 · 2011-06-10
  FDA Approved: JANUMET — Supplemental Application (Merck Sharp & Dohme LLC)

  FDA approved a supplemental application for JANUMET (sitagliptin/metformin hydrochloride) submitted by Merck Sharp & Dohme LLC, updating the…

• FDA approval · 2011-05-31
  FDA Approved: GLYBURIDE — Supplemental Application (Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.)

  FDA approved a supplemental application for glyburide from Heritage Pharmaceuticals (Avet) to an already-approved generic product (ANDA), in…

• FDA approval · 2011-05-25
  FDA Approved: ACARBOSE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  The FDA approved a supplemental application for acarbose (ACARBOSE) from Hikma Pharmaceuticals USA Inc., updating an existing approval for t…

• FDA approval · 2011-05-25
  FDA Approved: GLIPIZIDE — Supplemental Application (ANI Pharmaceuticals, Inc.)

  The FDA approved ANI Pharmaceuticals, Inc.'s supplemental application for glipizide (generic).

• FDA approval · 2011-05-18
  FDA Approved: INSULIN LISPRO — Supplemental Application (Eli Lilly and Company)

  FDA approved a supplemental application for insulin lispro from Eli Lilly, reflecting a labeling or formulation update under the supplementa…

• FDA approval · 2011-05-18
  FDA Approved: LIRAGLUTIDE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approves Teva Pharmaceuticals USA, Inc.'s supplemental application for liraglutide.

• FDA approval · 2011-05-02
  FDA Approved: TRADJENTA — Original Application (Boehringer Ingelheim Pharmaceuticals, Inc.)

  FDA approved Tradjenta (linagliptin) as a new treatment for type 2 diabetes, representing the original approval of this DPP-4 inhibitor.

• FDA approval · 2011-04-14
  FDA Approved: JANUVIA — Supplemental Application (Merck Sharp & Dohme LLC)

  FDA approved a supplemental application for Januvia (sitagliptin) submitted by Merck Sharp & Dohme LLC. The action updates the regulatory st…

• FDA approval · 2011-04-14
  FDA Approved: JANUMET — Supplemental Application (Merck Sharp & Dohme LLC)

  FDA approved a supplemental application for JANUMET (sitagliptin/metformin hydrochloride) filed by Merck Sharp & Dohme LLC.