Takeda resubmits NDAs for diabetes compounds

Takeda Pharmaceutical Co. Ltd. (Tokyo:4502) resubmitted NDAs to FDA for two Type II diabetes products: alogliptin and a fixed-dose combination of alogliptin and Actos pioglitazone. The resubmission includes additional data from three Phase III trials and postmarketing data from outside the U.S. Based on a June meeting with FDA, Takeda believes the additional data will address the agency's request in an April complete response letter. Details on the data were not disclosed. ...