US FDA sets new PDUFA action date for Vifor's Injectafer NDA

Vifor Pharma, a unit of Switzerland’s Galenica Group (SIX: GALN), says that its US partner, Luitpold Pharmaceuticals, a subsidiary of Japanese drug major Daiichi Sankyo (TKO: 4568), has received confirmation from the US Food and Drug Administration that the New Drug Application for the intravenous iron preparation Injectafer (ferric carboxymaltose) has been accepted for review with a PDUFA (Prescription Drug User Fee Act) target action date of July 30, 2013.

In July 2012, Luitpold received a Complete Response Letter from the FDA in which the agency noted its decision to withhold approval of Injectafer (the US brand name for Ferinject), for the treatment of iron deficiency anemia, until issues identified by the FDA at the company's Shirley manufacturing facility had been resolved. The FDA noted that its decision to withhold approval at that time was unrelated to the NDA filing for Injectafer. No additional clinical data or further analysis of the filing was requested.

In accordance with FDA standard procedure following receipt of a CRL, Luitpold resubmitted its application. In the light of this resubmission, the FDA has now informed Luitpold that its file will be subject to a review with a target action date of 30 July, 2013.