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Nesina Approval History

FDA Approved: Yes (First approved January 25, 2013)
Brand name: Nesina
Generic name: alogliptin
Dosage form: Tablets
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.

Development History and FDA Approval Process 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 theU.S.

Further information

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