Type 2 Diabetes Mellitus

• FDA approval · 2018-12-20
  FDA Approved: BYETTA — Supplemental Application (AstraZeneca Pharmaceuticals LP)

  FDA approved a supplemental application for BYETTA (exenatide) submitted by AstraZeneca Pharmaceuticals LP. The action updates the labeling …

• FDA approval · 2018-12-20
  FDA Approved: APIDRA — Supplemental Application (sanofi-aventis U.S. LLC)

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

• FDA approval · 2018-12-17
  FDA Approved: PIOGLITAZONE — Supplemental Application (NorthStar RxLLC)

  The FDA approved a supplemental application for pioglitazone submitted by NorthStar RxLLC. This action adds to the existing approval of the …

• FDA approval · 2018-12-11
  FDA Approved: INSULIN LISPRO — Supplemental Application (Eli Lilly and Company)

  The FDA approved a supplemental Biologics License Application for insulin lispro from Eli Lilly, authorizing changes to the product's labeli…

• FDA approval · 2018-11-30
  FDA Approved: NATEGLINIDE — Supplemental Application (Dr. Reddy's Laboratories Limited)

  FDA approved a supplemental application for nateglinide by Dr. Reddy's Laboratories Limited.

• Want full summaries, importance scores, and drug timelines? Upgrade to Plus or Pro.
• FDA approval · 2018-11-30
  FDA Approved: PIOGLITAZONE HYDROCHLORIDE — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for Pioglitazone hydrochloride from Aurobindo Pharma Limited, updating an already approved product.

• FDA approval · 2018-11-29
  FDA Approved: LANTUS SOLOSTAR — Supplemental Application (sanofi-aventis U.S. LLC)

  The FDA approved a supplemental application for LANTUS SOLOSTAR (insulin glargine) submitted by sanofi-aventis U.S. LLC.

• FDA approval · 2018-11-26
  FDA Approved: PIOGLITAZONE HYDROCHLORIDE — Supplemental Application (Chartwell RX, LLC)

  FDA approved a supplemental application for pioglitazone hydrochloride (generic), with Chartwell RX, LLC listed as the sponsor/manufacturer.

• FDA approval · 2018-11-26
  FDA Approved: PIOGLITAZONE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved Teva's supplemental application for Pioglitazone (generic) under ANDA. Pioglitazone is used to treat type 2 diabetes mellitus.

• FDA approval · 2018-11-26
  FDA Approved: GLIMEPIRIDE — Supplemental Application (Florida Pharmaceutical Products, LLC)

  FDA approved a supplemental application for glimepiride from Florida Pharmaceutical Products, LLC.

• FDA approval · 2018-11-19
  FDA Approved: NATEGLINIDE — Supplemental Application (Zydus Lifesciences Limited)

  FDA approved a supplemental application for Nateglinide from Zydus Lifesciences Limited.

• FDA approval · 2018-11-06
  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 · 2018-11-06
  FDA Approved: RIOMET — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved a Sun Pharmaceutical supplemental application for RIOMET (metformin hydrochloride), updating the product's regulatory status.

• FDA approval · 2018-11-02
  FDA Approved: METFORMIN — Original Application (Ingenus Pharmaceuticals, LLC)

  FDA approval of Ingenus Pharmaceuticals' generic metformin (METFORMIN) under an original ANDA, expanding access to metformin tablets for typ…

• FDA approval · 2018-11-01
  FDA Approved: INSULIN LISPRO — Supplemental Application (Eli Lilly and Company)

  The FDA approved a supplemental application for INSULIN LISPRO submitted by Eli Lilly and Company.

• FDA approval · 2018-10-29
  FDA Approved: INVOKAMET — Supplemental Application (Janssen Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for INVOKAMET (canagliflozin and metformin hydrochloride) from Janssen Pharmaceuticals, Inc. The…

• FDA approval · 2018-10-29
  FDA Approved: INVOKAMET XR — Supplemental Application (Janssen Pharmaceuticals, Inc.)

  FDA approved a supplemental application for INVOKAMET XR (canagliflozin and metformin HCl) from Janssen Pharmaceuticals, Inc. under NDA 2058…

• FDA approval · 2018-10-26
  FDA Approved: SEGLUROMET — Supplemental Application (Merck Sharp & Dohme LLC)

  FDA approved a supplemental application for Segluromet (ertugliflozin and metformin hydrochloride) from Merck Sharp & Dohme LLC. The action …

• FDA approval · 2018-10-26
  FDA Approved: INVOKANA — Supplemental Application (Janssen Pharmaceuticals, Inc.)

  The FDA has approved a supplemental application for INVOKANA (canagliflozin) submitted by Janssen Pharmaceuticals, Inc. The approval updates…

• FDA approval · 2018-10-26
  FDA Approved: INVOKAMET — Supplemental Application (Janssen Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for INVOKAMET, a fixed-dose combination of canagliflozin and metformin hydrochloride, submitted …

• FDA approval · 2018-10-26
  FDA Approved: DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE — Supplemental Application (Prasco Laboratories)

  FDA approved a supplemental application for Dapagliflozin and Metformin Hydrochloride (Prasco Laboratories), expanding the label for this co…

• FDA approval · 2018-10-26
  FDA Approved: INVOKAMET XR — Supplemental Application (Janssen Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for INVOKAMET XR (canagliflozin and metformin hydrochloride) submitted by Janssen Pharmaceutical…

• FDA approval · 2018-10-26
  FDA Approved: STEGLATRO — Supplemental Application (Merck Sharp & Dohme LLC)

  The FDA approved a supplemental application for STEGLATRO (ertugliflozin) from Merck Sharp & Dohme LLC.

• FDA approval · 2018-10-26
  FDA Approved: FARXIGA — Supplemental Application (AstraZeneca Pharmaceuticals LP)

  FDA approved a supplemental application for Farxiga (dapagliflozin) from AstraZeneca Pharmaceuticals LP.

• FDA approval · 2018-10-26
  FDA Approved: GLYXAMBI — Supplemental Application (Boehringer Ingelheim Pharmaceuticals, Inc.)

  FDA approved a supplemental application for GLYXAMBI (empagliflozin and linagliptin) submitted by Boehringer Ingelheim Pharmaceuticals, Inc.…