Type 2 Diabetes Mellitus

• FDA approval · 2011-04-13
  FDA Approved: METFORMIN HYDROCHLORIDE — Supplemental Application (Oceanside Pharmaceuticals)

  The FDA approved Oceanside Pharmaceuticals' supplemental NDA for metformin hydrochloride, resulting in updated labeling for this product.

• FDA approval · 2011-02-28
  FDA Approved: GLYBURIDE — Original Application (Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.)

  FDA approves the original application for the generic drug glyburide. The applicant is Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceutic…

• FDA approval · 2011-02-07
  FDA Approved: GLUCOTROL XL — Supplemental Application (Roerig)

  The FDA approved a supplemental application for Glucotrol XL (glipizide) submitted by Roerig, indicating a change or addition to the existin…

• FDA approval · 2011-02-03
  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 · 2011-01-31
  FDA Approved: GLIPIZIDE AND METFORMIN HYDROCHLORIDE — Original Application (Zydus Pharmaceuticals USA Inc.)

  The FDA approved a generic fixed-dose combination tablet of glipizide and metformin hydrochloride under an Original Application (ANDA) from …

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• FDA approval · 2010-12-27
  FDA Approved: NOVOLIN R — Supplemental Application (Novo Nordisk)

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

• FDA approval · 2010-12-22
  FDA Approved: LIRAGLUTIDE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved Teva Pharmaceuticals USA, Inc.'s supplemental application for liraglutide. This action updates the regulatory status of the lir…

• FDA approval · 2010-12-06
  FDA Approved: RIOMET — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

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

• FDA approval · 2010-11-19
  FDA Approved: METFORMIN HYDROCHLORIDE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved a supplemental application for Metformin Hydrochloride (Sun Pharmaceutical Industries, Inc.), a generic metformin product.

• FDA approval · 2010-11-12
  FDA Approved: BYETTA — Supplemental Application (AstraZeneca Pharmaceuticals LP)

  The FDA approved a supplemental application for BYETTA (exenatide) submitted by AstraZeneca Pharmaceuticals LP, indicating regulatory action…

• FDA approval · 2010-11-01
  FDA Approved: METFORMIN HYDROCHLORIDE — Original Application (Ascend Laboratories, LLC)

  The FDA approved Ascend Laboratories, LLC's metformin hydrochloride as an original ANDA, providing a generic version of metformin for type 2…

• FDA approval · 2010-09-24
  FDA Approved: JANUMET — Supplemental Application (Merck Sharp & Dohme LLC)

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

• FDA approval · 2010-09-23
  FDA Approved: GLYBURIDE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved a supplemental application for glyburide from Teva Pharmaceuticals USA, Inc. The approval indicates changes to an already appro…

• FDA approval · 2010-09-23
  FDA Approved: PIOGLITAZONE AND GLIMEPIRIDE — Supplemental Application (Prasco Laboratories)

  The FDA approval of a supplemental application for Pioglitazone and Glimepiride submitted by Prasco Laboratories. This action pertains to a …

• FDA approval · 2010-09-14
  FDA Approved: WELCHOL — Supplemental Application (Cosette Pharmaceuticals, Inc.)

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

• FDA approval · 2010-08-13
  FDA Approved: BYETTA — Supplemental Application (AstraZeneca Pharmaceuticals LP)

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

• FDA approval · 2010-08-06
  FDA Approved: ACTOPLUS MET — Supplemental Application (Takeda Pharmaceuticals America, Inc.)

  FDA approved a supplemental application for ACTOPLUS MET (pioglitazone and metformin hydrochloride) by Takeda Pharmaceuticals America, Inc.

• FDA approval · 2010-06-23
  FDA Approved: GLYBURIDE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved a supplemental application for GLYBURIDE from Teva Pharmaceuticals USA, Inc. to modify an existing glyburide product.

• FDA approval · 2010-06-23
  FDA Approved: GLIPIZIDE AND METFORMIN HCL — Original Application (Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.)

  The FDA approved the original ANDA for GLIPIZIDE AND METFORMIN HCL, a generic fixed-dose combination for type 2 diabetes mellitus, manufactu…

• FDA approval · 2010-06-10
  FDA Approved: HUMULIN N — Supplemental Application (Eli Lilly and Company)

  The FDA approved a supplemental application for HUMULIN N (insulin human) filed by Eli Lilly and Company.

• FDA approval · 2010-05-26
  FDA Approved: METFORMIN HYDROCHLORIDE — Supplemental Application (Amneal Pharmaceuticals LLC)

  FDA approved a supplemental application for Metformin Hydrochloride from Amneal Pharmaceuticals LLC.

• FDA approval · 2010-05-20
  FDA Approved: METFORMIN HYDROCHLORIDE — Supplemental Application (PuraCap Laboratories LLC dba Blu Pharmaceuticals)

  FDA approved a supplemental application for metformin hydrochloride from PuraCap Laboratories LLC dba Blu Pharmaceuticals, adding an additio…

• FDA approval · 2010-05-05
  FDA Approved: GLYBURIDE AND METFORMIN HYDROCHLORIDE — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for glyburide and metformin hydrochloride from Aurobindo Pharma Limited. The product is indicated fo…

• FDA approval · 2010-04-28
  FDA Approved: GLYBURIDE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved a supplemental application for glyburide from Teva Pharmaceuticals USA, Inc. under an ANDA, representing a supplemental approva…

• FDA approval · 2010-04-22
  FDA Approved: METFORMIN HYDROCHLORIDE — Original Application (Granules Pharmaceuticals Inc.)

  FDA approved Granules Pharmaceuticals Inc.'s original application for metformin hydrochloride tablets (generic metformin).