Liovel alogliptin/pioglitazone regulatory update

Takeda said FDA extended the PDUFA date by 3 months for NDAs for 2 Type II diabetes products to April 25, 2012, from Jan. 25. The products are alogliptin and a fixed-dose combination of alogliptin and Actos pioglitazone. According to Takeda, FDA needed more time to review additional information on postmarketing surveillance submitted at the agency's request.

Takeda resubmitted the NDAs in July after FDA asked the company to conduct an additional cardiovascular study in 2009 complete response letters for both products. The resubmissions include interim results from the Phase III EXAMINE cardiovascular outcomes trial. ...