Wednesday, April 25, 2012

Taked suffers major setback - USFDA rejects Alogliptin

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.