Type 2 Diabetes Mellitus

• FDA approval · 2019-11-15
  FDA Approved: TOUJEO — Supplemental Application (Sanofi-Aventis U.S. LLC)

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

• FDA approval · 2019-11-15
  FDA Approved: XULTOPHY 100/3.6 — Supplemental Application (Novo Nordisk)

  FDA approved a supplemental application for XULTOPHY 100/3.6, a fixed-ratio combination of insulin degludec and liraglutide, from Novo Nordi…

• FDA approval · 2019-11-15
  FDA Approved: ADMELOG — Supplemental Application (Sanofi-Aventis U.S. LLC)

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

• FDA approval · 2019-11-05
  FDA Approved: METFORMIN HYDROCHLORIDE — Supplemental Application (Macleods Pharmaceuticals Limited)

  FDA approved a supplemental application for Metformin hydrochloride from Macleods Pharmaceuticals Limited.

• FDA approval · 2019-11-05
  FDA Approved: METFORMIN HYDROCHLORIDE — Supplemental Application (Macleods Pharmaceuticals Limited)

  FDA approved a supplemental application for Metformin Hydrochloride from Macleods Pharmaceuticals Limited. The action approves an update to …

• Want full summaries, importance scores, and drug timelines? Upgrade to Plus or Pro.
• FDA approval · 2019-10-30
  FDA Approved: GLYBURIDE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  The FDA approved a supplemental application for glyburide from Teva Pharmaceuticals USA, Inc., confirming approval of this generic product. …

• FDA approval · 2019-10-28
  FDA Approved: REPAGLINIDE — Supplemental Application (Rising Pharma Holdings, Inc.)

  The FDA approved a supplemental application for repaglinide submitted by Rising Pharma Holdings, Inc., resulting in changes to the drug's la…

• FDA approval · 2019-10-21
  FDA Approved: FIASP — Supplemental Application (Novo Nordisk)

  FDA approved a supplemental application for FIASP (insulin aspart injection) submitted by Novo Nordisk, updating the labeling.

• FDA approval · 2019-10-18
  FDA Approved: DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE — Supplemental Application (Prasco Laboratories)

  The FDA approved a supplemental application for a fixed-dose combination of dapagliflozin and metformin hydrochloride, submitted by Prasco L…

• FDA approval · 2019-10-11
  FDA Approved: GLIPIZIDE — Supplemental Application (Aurobindo Pharma Limited)

  The FDA approved a supplemental application from Aurobindo Pharma Limited for glipizide, enabling the marketing of a generic version of the …

• FDA approval · 2019-10-11
  FDA Approved: GLIPIZIDE — Supplemental Application (Northstar Rx LLC.)

  FDA approved a supplemental application for glipizide submitted by Northstar Rx LLC, granting a new approval for this generic diabetes medic…

• FDA approval · 2019-10-07
  FDA Approved: COLESEVELAM — Original Application (Zydus Lifesciences Limited)

  FDA approved the original application for COLESEVELAM by Zydus Lifesciences Limited, establishing a generic form of colesevelam for choleste…

• FDA approval · 2019-10-02
  FDA Approved: ACARBOSE — Supplemental Application (Chartwell RX, LLC)

  The FDA approved a supplemental application for acarbose submitted by Chartwell RX, LLC.

• FDA approval · 2019-09-20
  FDA Approved: OZEMPIC — Original Application (Novo Nordisk)

  FDA approval of the original application for OZEMPIC's oral semaglutide formulation by Novo Nordisk.

• FDA approval · 2019-09-13
  FDA Approved: COLESEVELAM HYDROCHLORIDE — Original Application (Bionpharma Inc.)

  FDA approved a generic version of colesevelam hydrochloride (Colesevelam HCl) by Bionpharma Inc. under an original ANDA, for lipid-lowering …

• FDA approval · 2019-09-05
  FDA Approved: METFORMIN HYDROCHLORIDE — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  FDA approved Lupin Pharmaceuticals' supplemental application for metformin hydrochloride, authorizing a generic version of metformin hydroch…

• FDA approval · 2019-08-28
  FDA Approved: METFORMIN HYDROCHLORIDE — Supplemental Application (PuraCap Laboratories LLC dba Blu Pharmaceuticals)

  FDA approved a supplemental application for metformin hydrochloride (generic) submitted by PuraCap Laboratories LLC dba Blu Pharmaceuticals.

• FDA approval · 2019-08-27
  FDA Approved: METFORMIN HYDROCHLORIDE — Supplemental Application (Amneal Pharmaceuticals of New York LLC)

  The FDA approved a supplemental application for Metformin Hydrochloride from Amneal Pharmaceuticals of New York LLC, sanctioning changes to …

• FDA approval · 2019-08-27
  FDA Approved: METFORMIN HYDROCHLORIDE — Supplemental Application (Amneal Pharmaceuticals LLC)

  The FDA approved a supplemental application for metformin hydrochloride from Amneal Pharmaceuticals LLC, a generic formulation.

• FDA approval · 2019-08-27
  FDA Approved: METFORMIN HYDROCHLORIDE — Supplemental Application (Marlex Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for Metformin Hydrochloride (generic) submitted by Marlex Pharmaceuticals, Inc., confirming/expa…

• FDA approval · 2019-08-22
  FDA Approved: HUMULIN 70/30 — Supplemental Application (Eli Lilly and Company)

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

• FDA approval · 2019-08-13
  FDA Approved: HUMALOG KWIKPEN — Supplemental Application (Eli Lilly and Company)

  FDA approved a supplemental application for HUMALOG KWIKPEN (insulin lispro) from Eli Lilly and Company.

• FDA approval · 2019-08-12
  FDA Approved: JANUVIA — Supplemental Application (Merck Sharp & Dohme LLC)

  The FDA grants approval of a supplemental application for JANUVIA (sitagliptin) submitted by Merck Sharp & Dohme LLC.

• FDA approval · 2019-08-12
  FDA Approved: JANUMET — Supplemental Application (Merck Sharp & Dohme LLC)

  The FDA approved a supplemental application for JANUMET (sitagliptin and metformin HCl) from Merck Sharp & Dohme LLC, updating the labeling …

• FDA approval · 2019-08-12
  FDA Approved: JANUMET XR — Supplemental Application (Merck Sharp & Dohme LLC)

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