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