FDA Extends Review Of Takeda’s NDA For FDC Of Alogliptin, ACTOS

FDA has extended the review of Takeda’s New Drug Application (NDA) for the fixed-dose combination (FDC) of alogliptin and ACTOS (pioglitazone HCl).

Reportedly, the NDA for the FDC of alogliptin and ACTOS was submitted in September 2008, following the NDA submission of alogliptin monotherapy in December 2007.

ACTOS is a prescription medication used with diet and exercise to improve blood sugar (glucose) control in adults with type 2 diabetes, said the company.

Takeda market oral diabetes, insomnia, rheumatology and gastroenterology treatments. The company has a product pipeline that includes compounds in development for diabetes, cardiovascular disease, gastroenterology, neurology and other conditions.