USFDA has once again rejected approval of Alogliptin (DPP-IV Inhibitor) - Takeda
has said the USFDA needs additional data, which it would be able to
supply from ongoing clincial research and post marketing data that they
have collated. The delay would stretch approval timelines atleast 1 to 2 years. With such a late entry, it is unlikely to get a meaningful share, even if it is approved.
