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Oseni FDA Approval History

FDA Approved: Yes (First approved January 25, 2013)
Brand name: Oseni
Generic name: alogliptin and pioglitazone
Dosage form: Tablets
Previous Name: SYR-322/Actos
Company: Takeda Pharmaceutical Company Limited
Treatment for: Type 2 Diabetes

Oseni (alogliptin and pioglitazone) is a dipeptidyl peptidase-4 (DPP-4) inhibitor and thiazolidinedione fixed-dose combination for the treatment of type 2 diabetes.

Development timeline for Oseni

DateArticle
Jan 25, 2013Approval Takeda Receives FDA Approval for Oseni (alogliptin and pioglitazone) for Type 2 Diabetes
Sep  4, 2009Takeda Receives FDA Complete Response Letter for the Investigational Fixed-Dose Combination of alogliptin and Actos (pioglitazone HCl) for the Treatment of Type 2 Diabetes
Jul 23, 2009Takeda Provides Update on the Investigational Fixed-Dose Combination of alogliptin and Actos (pioglitazone HCl)
Sep 24, 2008Takeda Submits a New Drug Application in the U.S. for Alogliptin (SYR-322) / Actos (pioglitazone HCl) for the Treatment of Type 2 Diabetes

See also

Oseni (alogliptin and pioglitazone) Consumer information

Further information

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