Type 2 Diabetes Mellitus

• FDA approval · 2014-01-22
  FDA Approved: WELCHOL — Supplemental Application (Cosette Pharmaceuticals, Inc.)

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

• FDA approval · 2014-01-22
  FDA Approved: WELCHOL — Supplemental Application (Cosette Pharmaceuticals, Inc.)

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

• FDA approval · 2014-01-22
  FDA Approved: REPAGLINIDE — Original Application (Rising Pharma Holdings, Inc.)

  FDA approved Rising Pharma Holdings, Inc.'s original-application generic repaglinide for use in adults with type 2 diabetes mellitus.

• FDA approval · 2014-01-22
  FDA Approved: REPAGLINIDE — Original Application (Chartwell RX, LLC)

  FDA approved the original application for repaglinide (generic) by Chartwell RX, LLC, making a generic version of this meglitinide-type oral…

• FDA approval · 2014-01-10
  FDA Approved: PIOGLITAZONE — Original Application (Teva Pharmaceuticals USA, Inc.)

  FDA approves Teva's pioglitazone generic (Original Application) for type 2 diabetes mellitus. This marks the approval of a generic version a…

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• FDA approval · 2014-01-08
  FDA Approved: FARXIGA — Original Application (AstraZeneca Pharmaceuticals LP)

  FDA's original approval decision for Farxiga (dapagliflozin) by AstraZeneca, marking the initial marketing authorization for this SGLT2 inhi…

• FDA approval · 2013-12-18
  FDA Approved: JENTADUETO — Supplemental Application (Boehringer Ingelheim Pharmaceuticals, Inc.)

  FDA approved a supplemental application for JENTADUETO (linagliptin and metformin hydrochloride) from Boehringer Ingelheim Pharmaceuticals, …

• FDA approval · 2013-12-12
  FDA Approved: HUMULIN N — Supplemental Application (Eli Lilly and Company)

  FDA approved a supplemental application for HUMULIN N (insulin human) from Eli Lilly, granting a supplemental approval to the existing biolo…

• FDA approval · 2013-12-12
  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 · 2013-12-09
  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. This confirms regulatory approval …

• FDA approval · 2013-12-09
  FDA Approved: HUMULIN N — Supplemental Application (Eli Lilly and Company)

  FDA approved a supplemental application for Humulin N (insulin human) from Eli Lilly and Company.

• FDA approval · 2013-11-22
  FDA Approved: REPAGLINIDE — Original Application (Chartwell RX, LLC)

  The FDA approved Chartwell RX, LLC's original Abbreviated New Drug Application for repaglinide, a meglitinide used to improve glycemic contr…

• FDA approval · 2013-11-12
  FDA Approved: PIOGLITAZONE AND GLIMEPIRIDE — Supplemental Application (Prasco Laboratories)

  FDA approved a supplemental application from Prasco Laboratories to market Pioglitazone and Glimepiride as a fixed-dose combination.

• FDA approval · 2013-11-12
  FDA Approved: ACTOS — Supplemental Application (Takeda Pharmaceuticals America, Inc.)

  FDA approved a supplemental application for ACTOS (pioglitazone) submitted by Takeda Pharmaceuticals America, Inc., updating or expanding th…

• FDA approval · 2013-11-07
  FDA Approved: HUMULIN N — Supplemental Application (Eli Lilly and Company)

  The FDA approved a supplemental application for Humulin N (insulin human) from Eli Lilly and Company. This action updates the product's labe…

• FDA approval · 2013-10-31
  FDA Approved: LEVEMIR — Supplemental Application (Novo Nordisk)

  The FDA approved a supplemental application for LEVEMIR (insulin detemir) submitted by Novo Nordisk.

• FDA approval · 2013-10-18
  FDA Approved: LANTUS SOLOSTAR — Supplemental Application (sanofi-aventis U.S. LLC)

  FDA approved a supplemental application for LANTUS SOLOSTAR (insulin glargine) from Sanofi-Aventis U.S. LLC. This action approves changes to…

• FDA approval · 2013-10-17
  FDA Approved: JANUVIA — Supplemental Application (Merck Sharp & Dohme LLC)

  FDA approves a supplemental application for JANUVIA (sitagliptin) filed by Merck, updating the product's label/indication.

• FDA approval · 2013-10-17
  FDA Approved: JANUMET XR — Supplemental Application (Merck Sharp & Dohme LLC)

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

• FDA approval · 2013-10-17
  FDA Approved: KAZANO — Supplemental Application (Takeda Pharmaceuticals America, Inc.)

  FDA approved a supplemental application for KAZANO (alogliptin and metformin hydrochloride) submitted by Takeda Pharmaceuticals America, Inc…

• FDA approval · 2013-10-15
  FDA Approved: GLUCOTROL XL — Supplemental Application (Roerig)

  The FDA approved a supplemental application for Glucotrol XL (glipizide) submitted by Roerig.

• FDA approval · 2013-10-15
  FDA Approved: GLYBURIDE — Supplemental Application (TEVA Pharmaceuticals USA Inc)

  The FDA approved a supplemental application for glyburide from Teva Pharmaceuticals USA.

• FDA approval · 2013-09-16
  FDA Approved: RIOMET — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  FDA approves a supplemental application for RIOMET (metformin hydrochloride) from Sun Pharmaceutical Industries, Inc., updating or expanding…

• FDA approval · 2013-09-11
  FDA Approved: METFORMIN HYDROCHLORIDE — Original Application (Westminster Pharmaceuticals, LLC)

  FDA approves Westminster Pharmaceuticals' original application for metformin hydrochloride, a generic version of the diabetes medication.

• FDA approval · 2013-09-06
  FDA Approved: APIDRA — Supplemental Application (sanofi-aventis U.S. LLC)

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