Type 2 Diabetes Mellitus

• FDA approval · 2008-10-31
  FDA Approved: METFORMIN HYDROCHLORIDE — Supplemental Application (Viona Pharmaceuticals Inc)

  FDA approved a supplemental application for metformin hydrochloride (generic) from Viona Pharmaceuticals Inc, indicating an approved update …

• FDA approval · 2008-10-29
  FDA Approved: METFORMIN HYDROCHLORIDE — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental ANDA for Metformin Hydrochloride from Aurobindo Pharma Limited, authorizing the generic product's market entry.

• FDA approval · 2008-10-27
  FDA Approved: GLUCOTROL XL — Supplemental Application (Roerig)

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

• FDA approval · 2008-10-24
  FDA Approved: APIDRA — Supplemental Application (sanofi-aventis U.S. LLC)

  FDA approved a supplemental application for APIDRA (insulin glulisine) from Sanofi-aventis U.S. LLC.

• FDA approval · 2008-10-20
  FDA Approved: RIOMET — Original Application (Sun Pharmaceutical Industries, Inc.)

  The FDA approved RIOMET (metformin hydrochloride) under the original NDA for Sun Pharmaceutical Industries, establishing a new metformin pro…

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• FDA approval · 2008-10-20
  FDA Approved: JANUVIA — Supplemental Application (Merck Sharp & Dohme LLC)

  The FDA approved a supplemental application for Januvia (sitagliptin) filed by Merck Sharp & Dohme LLC.

• FDA approval · 2008-10-20
  FDA Approved: JANUMET — Supplemental Application (Merck Sharp & Dohme LLC)

  The FDA approved a supplemental application for JANUMET (sitagliptin and metformin hydrochloride) filed by Merck Sharp & Dohme LLC. This app…

• FDA approval · 2008-10-20
  FDA Approved: RIOMET — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved a supplemental application for RIOMET (metformin hydrochloride) by Sun Pharmaceutical Industries, Inc., updating the regulatory…

• FDA approval · 2008-10-09
  FDA Approved: METFORMIN HYDROCHLORIDE — Supplemental Application (Lifsa Drugs, LLC)

  FDA has approved a supplemental application for Metformin Hydrochloride (generic) from Lifsa Drugs, LLC under an ANDA, indicating an approve…

• FDA approval · 2008-10-01
  FDA Approved: BROMOCRIPTINE MESYLATE — Original Application (Padagis US LLC)

  FDA approved Padagis US LLC's original generic application for bromocriptine mesylate. This approval provides a generic version of bromocrip…

• FDA approval · 2008-09-03
  FDA Approved: LEVEMIR — Supplemental Application (Novo Nordisk)

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

• FDA approval · 2008-07-22
  FDA Approved: JANUVIA — Supplemental Application (Merck Sharp & Dohme LLC)

  FDA approved a supplemental application for Januvia (sitagliptin) from Merck Sharp & Dohme LLC.

• FDA approval · 2008-05-30
  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 · 2008-05-07
  FDA Approved: ACTOS — Supplemental Application (Takeda Pharmaceuticals America, Inc.)

  FDA approved a supplemental application for ACTOS (pioglitazone) filed by Takeda Pharmaceuticals America, Inc., authorizing a modification t…

• FDA approval · 2008-05-07
  FDA Approved: ACARBOSE — Original Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved the original application for acarbose (generic) from Hikma Pharmaceuticals USA Inc. The approval makes a generic version of aca…

• FDA approval · 2008-05-01
  FDA Approved: HUMALOG MIX50/50 KWIKPEN — Supplemental Application (Eli Lilly and Company)

  FDA approved a supplemental application for Humalog Mix50/50 KwikPen (insulin lispro) from Eli Lilly and Company.

• FDA approval · 2008-05-01
  FDA Approved: JANUMET — Supplemental Application (Merck Sharp & Dohme LLC)

  The FDA approved a supplemental application for JANUMET (sitagliptin and metformin hydrochloride) from Merck, resulting in changes to the pr…

• FDA approval · 2008-04-28
  FDA Approved: GLIMEPIRIDE — Supplemental Application (Solco Healthcare U.S., LLC)

  FDA approved a supplemental application for a generic glimepiride product from Solco Healthcare U.S., LLC.

• FDA approval · 2008-04-25
  FDA Approved: GLIPIZIDE — Supplemental Application (ANI Pharmaceuticals, Inc.)

  The FDA approved ANI Pharmaceuticals' supplemental application for glipizide, a generic oral therapy for type 2 diabetes mellitus.

• FDA approval · 2008-04-17
  FDA Approved: METFORMIN HYDROCHLORIDE — Original Application (Precision Dose, Inc.)

  FDA approved Precision Dose, Inc.'s original ANDA for Metformin Hydrochloride tablets, a generic metformin product for type 2 diabetes melli…

• FDA approval · 2008-03-20
  FDA Approved: METFORMIN HYDROCHLORIDE — Supplemental Application (Amneal Pharmaceuticals of New York LLC)

  FDA approval of a supplemental application for metformin hydrochloride by Amneal Pharmaceuticals of New York LLC.

• FDA approval · 2008-03-14
  FDA Approved: NOVOLOG — Supplemental Application (Novo Nordisk)

  The FDA approved a supplemental application for NovoLOG (insulin aspart) from Novo Nordisk, signaling an approved change to the product's la…

• FDA approval · 2008-02-29
  FDA Approved: METFORMIN HYDROCHLORIDE — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA approved a supplemental application for metformin hydrochloride (Mylan Pharmaceuticals Inc.) to update/expand labeling for the product.

• FDA approval · 2008-02-26
  FDA Approved: JANUMET — Supplemental Application (Merck Sharp & Dohme LLC)

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

• FDA approval · 2008-02-12
  FDA Approved: METFORMIN HYDROCHLORIDE — Supplemental Application (Lifsa Drugs, LLC)

  The FDA approved a supplemental application for Lifsa Drugs' metformin hydrochloride, a generic metformin product.