Type 2 Diabetes Mellitus

• FDA approval · 2015-02-25
  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, expanding the approved formulation…

• FDA approval · 2015-02-25
  FDA Approved: HUMULIN R — Supplemental Application (Eli Lilly and Company)

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

• FDA approval · 2015-02-24
  FDA Approved: MIGLITOL — Original Application (Westminster Pharmaceuticals, LLC)

  FDA approved the Original Application for Miglitol (generic alpha-glucosidase inhibitor) from Westminster Pharmaceuticals, LLC.

• FDA approval · 2015-02-23
  FDA Approved: IRBESARTAN — Original Application (AvKARE)

  FDA approved AvKARE's original generic application for irbesartan (IRBESARTAN). Irbesartan is used to treat hypertension.

• FDA approval · 2015-02-18
  FDA Approved: GLYBURIDE AND METFORMIN HYDROCHLORIDE — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application from Aurobindo Pharma Limited for a glyburide and metformin hydrochloride combination tablet. The pr…

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• FDA approval · 2015-02-18
  FDA Approved: GLYBURIDE-METFORMIN HYDROCHLORIDE — Supplemental Application (Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.)

  FDA approved a supplemental application for Glyburide-Metformin Hydrochloride from Heritage Pharmaceuticals d/b/a Avet Pharmaceuticals Inc.,…

• FDA approval · 2015-02-18
  FDA Approved: GLYBURIDE — Supplemental Application (Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.)

  FDA approved a supplemental application for the generic diabetes drug glyburide from Heritage Pharmaceuticals (Avet) under ANDA 090937.

• FDA approval · 2015-01-30
  FDA Approved: GLYXAMBI — Original Application (Boehringer Ingelheim Pharmaceuticals, Inc.)

  GLYXAMBI (empagliflozin and linagliptin) received FDA approval as a fixed-dose combination product for adults with Type 2 diabetes mellitus.…

• FDA approval · 2015-01-26
  FDA Approved: INSULIN LISPRO — Supplemental Application (Eli Lilly and Company)

  FDA approved a supplemental application for insulin lispro from Eli Lilly, including the associated diluent as part of the approved product.

• FDA approval · 2015-01-23
  FDA Approved: NOVOLOG — Supplemental Application (Novo Nordisk)

  The FDA approved a supplemental application for NovoLog (insulin aspart) from Novo Nordisk, expanding the product’s regulatory authorization…

• FDA approval · 2015-01-23
  FDA Approved: LEVEMIR — Supplemental Application (Novo Nordisk)

  The FDA approved a supplemental application for LEVEMIR (insulin detemir) from Novo Nordisk, resulting in changes to the product labeling as…

• FDA approval · 2015-01-16
  FDA Approved: GLYBURIDE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  The FDA approved a supplemental application for Glyburide from Teva Pharmaceuticals USA, Inc., updating an existing glyburide product under …

• FDA approval · 2015-01-14
  FDA Approved: NOVOLOG — Supplemental Application (Novo Nordisk)

  FDA approved NovoLog (insulin aspart) supplemental application submitted by Novo Nordisk. This action represents a supplemental approval, li…

• FDA approval · 2015-01-12
  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. This action confirms approval of a supplem…

• FDA approval · 2014-12-22
  FDA Approved: METFORMIN HCL — Supplemental Application (TIME CAP LABORATORIES, INC)

  The FDA approved a supplemental application for METFORMIN HCL from Time Cap Laboratories, Inc., indicating regulatory acceptance of changes …

• FDA approval · 2014-12-19
  FDA Approved: TRULICITY — Supplemental Application (Eli Lilly and Company)

  FDA approved a supplemental application for TRULICITY (dulaglutide) from Eli Lilly, indicating an update to the product's labeling/indicatio…

• FDA approval · 2014-12-11
  FDA Approved: GLYBURIDE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approves a supplemental application for glyburide (Teva Pharmaceuticals USA, Inc.).

• FDA approval · 2014-12-03
  FDA Approved: GLIMEPIRIDE — Supplemental Application (Micro Labs Limited)

  FDA approves a supplemental application for a generic version of glimepiride manufactured by Micro Labs Limited.

• FDA approval · 2014-12-02
  FDA Approved: METFORMIN HYDROCHLORIDE — Supplemental Application (Westminster Pharmaceuticals, LLC)

  FDA approved Westminster Pharmaceuticals, LLC's supplemental application for METFORMIN HYDROCHLORIDE (metformin hydrochloride), approving an…

• FDA approval · 2014-11-24
  FDA Approved: BYETTA — Supplemental Application (AstraZeneca Pharmaceuticals LP)

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

• FDA approval · 2014-11-11
  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 · 2014-11-03
  FDA Approved: GLIMEPIRIDE — Supplemental Application (Accord Healthcare Inc)

  FDA approved a supplemental application for glimepiride filed by Accord Healthcare Inc.

• FDA approval · 2014-10-30
  FDA Approved: HUMULIN R — Supplemental Application (Eli Lilly and Company)

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

• FDA approval · 2014-10-29
  FDA Approved: DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE — Original Application (Prasco Laboratories)

  The FDA approved a fixed-dose combination tablet of dapagliflozin and metformin hydrochloride from Prasco Laboratories for adults with type …

• FDA approval · 2014-09-30
  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.