Nesina Approval History

  • FDA approved: Yes (First approved January 25th, 2013)
  • Brand name: Nesina
  • Generic name: alogliptin
  • Previous name: SYR-322
  • Company: Takeda Pharmaceutical Company Limited
  • Treatment for: Diabetes, Type 2

Nesina (alogliptin) is a dipeptidyl peptidase-4 (DPP-4) inhibitor for the treatment of type 2 diabetes.

FDA Approval History for Nesina

DateArticle
Jan 25, 2013Approval Takeda Receives FDA Approval for Nesina (alogliptin) for Type 2 Diabetes
Jul 27, 2012Takeda Resubmits New Drug Applications to the United States Food and Drug Administration for Alogliptin and the Fixed-Dose Combination Alogliptin and Pioglitazone
Apr 27, 2012Takeda Receives Complete Response Letter from the FDA for Type 2 Diabetes Investigational Therapies Alogliptin and Fixed-Dose Combination Alogliptin and Pioglitazone
Apr 26, 2012Furiex Confirms Takeda's Receipt of Complete Response Letter from the FDA for Alogliptin and Fixed-Dose Combination Alogliptin and Pioglitazone
Nov 18, 2011U.S. Food and Drug Administration (FDA) Delays Review of Takeda's Investigational Type 2 Diabetes Therapies, Alogliptin and Alogliptin/Pioglitazone
Nov  1, 2011Takeda Announces PDUFA Action Date for Investigational Type 2 Diabetes Therapies Alogliptin and the Fixed-Dose Combination Alogliptin/Pioglitazone
Jul 26, 2011Takeda Resubmits New Drug Applications in the U.S. for Investigational Type 2 Diabetes Therapies Alogliptin and the Fixed-Dose Combination Alogliptin/Pioglitazone
Aug 28, 2009Takeda Initiates Cardiovascular Outcomes Trial for Alogliptin, An Investigational Treatment for Type 2 Diabetes
Jun 28, 2009Takeda Receives FDA Complete Response Letter for Alogliptin, an Investigational Treatment for Type 2 Diabetes
Mar  6, 2009Takeda Receives New Information on Alogliptin (SYR-322) NDA
Dec 24, 2008Takeda Receives New Action Date for Alogliptin (SYR-322) NDA
Oct 10, 2008FDA Continues Review of Takeda's New Drug Application for Alogliptin (SYR-322), a DPP-4 Agent for Type 2 Diabetes
Feb 29, 2008PPD Confirms Takeda's NDA Filing of Alogliptin with U.S. Food and Drug Administration
Jan  4, 2008Takeda Submits New Drug Application for Alogliptin (SYR-322) in the U.S.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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