Oseni Approval History

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

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

FDA Approval History 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

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.

Hide
(web5)