Type 2 Diabetes Mellitus

• FDA approval · 2019-05-06
  FDA Approved: COLESEVELAM HYDROCHLORIDE — Original Application (Ascend Laboratories, LLC)

  FDA approved an original application for Colesevelam hydrochloride (generic) from Ascend Laboratories, LLC.

• FDA approval · 2019-04-23
  FDA Approved: GLIPIZIDE — Supplemental Application (Rising Pharma Holdings, Inc.)

  The FDA approved a supplemental application for glipizide filed by Rising Pharma Holdings, Inc. under ANDA 204720.

• FDA approval · 2019-04-19
  FDA Approved: NATEGLINIDE — Original Application (Modavar Pharmaceuticals LLC)

  FDA approved the original application for a generic Nateglinide product from Modavar Pharmaceuticals LLC. It is used to improve glycemic con…

• FDA approval · 2019-04-17
  FDA Approved: METFORMIN HYDROCHLORIDE — Supplemental Application (Macleods Pharmaceuticals Limited)

  The FDA approved a supplemental application for Metformin Hydrochloride from Macleods Pharmaceuticals Limited (ANDA206955), typically involv…

• FDA approval · 2019-04-10
  FDA Approved: WELCHOL — Supplemental Application (Cosette Pharmaceuticals, Inc.)

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

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• FDA approval · 2019-04-09
  FDA Approved: OZEMPIC — Supplemental Application (Novo Nordisk)

  The FDA approved a supplemental application for OZEMPIC (semaglutide) from Novo Nordisk.

• FDA approval · 2019-03-06
  FDA Approved: PIOGLITAZONE AND METFORMIN HYDROCHLORIDE — Supplemental Application (Macleods Pharmaceuticals Limited)

  FDA approved a supplemental application for Pioglitazone and Metformin Hydrochloride (Macleods Pharmaceuticals Limited). This fixed-dose com…

• FDA approval · 2019-03-01
  FDA Approved: METFORMIN HYDROCHLORIDE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved a supplemental application for metformin hydrochloride submitted by Sun Pharmaceutical Industries, Inc., confirming/adding appr…

• FDA approval · 2019-02-27
  FDA Approved: XULTOPHY 100/3.6 — Supplemental Application (Novo Nordisk)

  The FDA approved a supplemental application to add the XULTOPHY 100/3.6 strength, a fixed-ratio combination of insulin degludec and liraglut…

• FDA approval · 2019-02-27
  FDA Approved: SOLIQUA 100/33 — Supplemental Application (Sanofi-Aventis U.S. LLC)

  The FDA approved a supplemental application for Soliqua 100/33 (insulin glargine and lixisenatide) from Sanofi-Aventis U.S. LLC.

• FDA approval · 2019-02-22
  FDA Approved: PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for Pioglitazone hydrochloride and metformin hydrochloride (Aurobindo Pharma Limited), a generic com…

• FDA approval · 2019-02-22
  FDA Approved: METFORMIN HCL — Supplemental Application (TIME CAP LABORATORIES, INC)

  The FDA approved a supplemental application for METFORMIN HCL by Time Cap Laboratories, Inc., under ANDA 090888. The product is a generic me…

• FDA approval · 2019-02-22
  FDA Approved: METFORMIN HYDROCHLORIDE — Supplemental Application (Westminster Pharmaceuticals, LLC)

  FDA approved a supplemental application for Metformin Hydrochloride (generic) submitted by Westminster Pharmaceuticals, LLC.

• FDA approval · 2019-02-22
  FDA Approved: DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE — Supplemental Application (Prasco Laboratories)

  FDA approved a supplemental application for Dapagliflozin and Metformin Hydrochloride, a fixed-dose combination product from Prasco Laborato…

• FDA approval · 2019-02-22
  FDA Approved: METFORMIN HYDROCHLORIDE — Supplemental Application (Granules Pharmaceuticals Inc.)

  The FDA approved Granules Pharmaceuticals Inc.'s supplemental application for METFORMIN HYDROCHLORIDE, indicating an approved modification t…

• FDA approval · 2019-02-14
  FDA Approved: METFORMIN HYDROCHLORIDE — Supplemental Application (Aurobindo Pharma Limited)

  The FDA approved a supplemental application for metformin hydrochloride by Aurobindo Pharma Limited.

• FDA approval · 2019-02-02
  FDA Approved: METFORMIN HYDROCHLORIDE — Supplemental Application (Ascend Laboratories, LLC)

  FDA approved a supplemental application for metformin hydrochloride submitted by Ascend Laboratories, LLC.

• FDA approval · 2019-02-01
  FDA Approved: XULTOPHY 100/3.6 — Supplemental Application (Novo Nordisk)

  FDA approves a supplemental application for XULTOPHY 100/3.6, a fixed-ratio combination of insulin degludec and liraglutide, expanding its a…

• FDA approval · 2019-01-15
  FDA Approved: TRULICITY — Supplemental Application (Eli Lilly and Company)

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

• FDA approval · 2019-01-14
  FDA Approved: METFORMIN HYDROCHLORIDE — Supplemental Application (Mylan Pharmaceuticals Inc.)

  The FDA approved a supplemental application for metformin hydrochloride from Mylan Pharmaceuticals Inc., a generic metformin product. Metfor…

• FDA approval · 2019-01-14
  FDA Approved: METFORMIN ER 500 MG — Supplemental Application (Quallent Pharmaceuticals Health LLC)

  FDA approved a supplemental application for METFORMIN ER 500 MG from Quallent Pharmaceuticals Health LLC, with METFORMIN ER 750 MG listed as…

• FDA approval · 2019-01-04
  FDA Approved: GLYBURIDE — Original Application (Modavar Pharmaceuticals LLC)

  The FDA approved the original ANDA for glyburide (GLYBURIDE) from Modavar Pharmaceuticals LLC, enabling generic access to this sulfonylurea.…

• FDA approval · 2019-01-02
  FDA Approved: METFORMIN HYDROCHLORIDE — Supplemental Application (Precision Dose, Inc.)

  FDA approved a supplemental application for metformin hydrochloride from Precision Dose, Inc., under the existing NDA.

• FDA approval · 2019-01-02
  FDA Approved: METFORMIN HYDROCHLORIDE — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for metformin hydrochloride by Aurobindo Pharma Limited under ANDA079118. This action confirms appro…

• FDA approval · 2018-12-27
  FDA Approved: METFORMIN HYDROCHLORIDE — Original Application (Qingdao BAHEAL Pharmaceutical Co., Ltd.)

  The FDA approved Qingdao BAHEAL Pharmaceutical Co., Ltd.'s metformin hydrochloride extended-release tablets under an Original Application (A…