Vifor Pharma has announced that its US partner, Luitpold Pharmaceuticals, Inc., has received confirmation from the US Food and Drug Administration (FDA) that the New Drug Application (NDA) for the intravenous iron preparation Injectafer® has been accepted for review with a PDUFA (Prescription Drug User Fee Act) target action date of 30 July, 2013.
In July 2012, Luitpold Pharmaceuticals, Inc., received a Complete Response Letter from the FDA in which the agency noted its decision to withhold approval of Injectafer® (US brand name of Ferinject®, ferric carboxymaltose) for the treatment of iron deficiency anaemia, 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 New Drug Application 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 Complete Response Letter, Luitpold resubmitted their application. In the light of this resubmission, the FDA has now informed Luitpold that their file will be subject to a review with a target action date of 30 July, 2013.
Ferinject® was approved by both the Swiss regulatory agency Swissmedic and the UK Medicines & Healthcare products Regulatory Agency (MHRA) in 2007. With the UK as Reference country, the MHRA has supported the subsequent approval of Ferinject® throughout the EU. Ferinject® is currently registered for use in 45 countries worldwide.