Type 2 Diabetes Mellitus

• FDA approval · 2014-05-22
  FDA Approved: JENTADUETO — Supplemental Application (Boehringer Ingelheim Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for JENTADUETO, the fixed-dose combination of linagliptin and metformin hydrochloride, submitted…

• FDA approval · 2014-05-20
  FDA Approved: WELCHOL — Supplemental Application (Cosette Pharmaceuticals, Inc.)

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

• FDA approval · 2014-04-23
  FDA Approved: BYETTA — Supplemental Application (AstraZeneca Pharmaceuticals LP)

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

• FDA approval · 2014-04-11
  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. The action updates the product's label…

• FDA approval · 2014-04-11
  FDA Approved: HUMALOG MIX75/25 — Supplemental Application (Eli Lilly and Company)

  FDA approved a supplemental application for HUMALOG MIX75/25 (insulin lispro) submitted by Eli Lilly and Company.

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• FDA approval · 2014-04-03
  FDA Approved: INSULIN LISPRO — Supplemental Application (Eli Lilly and Company)

  The FDA approved a supplemental application for insulin lispro from Eli Lilly, adding to the existing approval for this product. This action…

• FDA approval · 2014-04-01
  FDA Approved: INSULIN LISPRO — Supplemental Application (Eli Lilly and Company)

  FDA approved a supplemental application for insulin lispro submitted by Eli Lilly and Company.

• FDA approval · 2014-03-24
  FDA Approved: GLYBURIDE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved a supplemental application for glyburide by Teva Pharmaceuticals USA, Inc. under ANDA074686.

• FDA approval · 2014-03-20
  FDA Approved: METFORMIN HYDROCHLORIDE — Supplemental Application (Westminster Pharmaceuticals, LLC)

  The FDA approved Westminster Pharmaceuticals, LLC's supplemental application for metformin hydrochloride.

• FDA approval · 2014-03-18
  FDA Approved: INSULIN LISPRO — Supplemental Application (Eli Lilly and Company)

  FDA approved a supplemental application for insulin lispro from Eli Lilly and Company.

• FDA approval · 2014-03-18
  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. The document not…

• FDA approval · 2014-03-18
  FDA Approved: HUMULIN 70/30 — Supplemental Application (Eli Lilly and Company)

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

• FDA approval · 2014-03-18
  FDA Approved: HUMALOG MIX50/50 KWIKPEN — Supplemental Application (Eli Lilly and Company)

  The FDA approved a supplemental application for HUMALOG MIX50/50 KWIKPEN (insulin lispro) from Eli Lilly and Company; this action updates th…

• FDA approval · 2014-03-11
  FDA Approved: WELCHOL — Supplemental Application (Cosette Pharmaceuticals, Inc.)

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

• FDA approval · 2014-03-04
  FDA Approved: LEVEMIR — Supplemental Application (Novo Nordisk)

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

• FDA approval · 2014-03-04
  FDA Approved: HUMULIN 70/30 — Supplemental Application (Eli Lilly and Company)

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

• FDA approval · 2014-03-04
  FDA Approved: NOVOLOG — Supplemental Application (Novo Nordisk)

  The FDA approved a supplemental application for NovoLog (insulin aspart) from Novo Nordisk. The approval covers changes to the product's lab…

• FDA approval · 2014-02-27
  FDA Approved: BROMOCRIPTINE MESYLATE — Supplemental Application (ANI Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for Bromocriptine Mesylate from ANI Pharmaceuticals, Inc., resulting in an updated approval for …

• FDA approval · 2014-02-25
  FDA Approved: NOVOLOG — Supplemental Application (Novo Nordisk)

  FDA approved a supplemental application for NovoLog (insulin aspart) from Novo Nordisk, representing an approved change to the existing BLA.

• FDA approval · 2014-02-12
  FDA Approved: JANUMET XR — Supplemental Application (Merck Sharp & Dohme LLC)

  FDA approves a supplemental application for JANUMET XR (sitagliptin/metformin hydrochloride) submitted by Merck Sharp & Dohme LLC.

• FDA approval · 2014-01-31
  FDA Approved: INSULIN LISPRO — Supplemental Application (Eli Lilly and Company)

  FDA approved a supplemental application for insulin lispro submitted by Eli Lilly and Company.

• FDA approval · 2014-01-30
  FDA Approved: BYETTA — Supplemental Application (AstraZeneca Pharmaceuticals LP)

  FDA approves a supplemental application for BYETTA (exenatide) from AstraZeneca Pharmaceuticals LP, resulting in an update to the product la…

• FDA approval · 2014-01-24
  FDA Approved: HUMULIN 70/30 — Supplemental Application (Eli Lilly and Company)

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

• FDA approval · 2014-01-24
  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. This action approves a supplemental submis…

• FDA approval · 2014-01-23
  FDA Approved: GLYBURIDE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved a supplemental application for glyburide submitted by Teva Pharmaceuticals USA, Inc.