Press release

New PDUFA action date announced by the US FDA for Injectafer® New Drug Application

Monday, 8 April 2013, ↓ directly to download

Galenica’s U.S. 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, site of Injectafer® production for the US market, 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 Pharmaceuticals, Inc. resubmitted their application. In the light of this resubmission, the FDA has now informed Luitpold Pharmaceuticals, Inc. 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 European Union. Ferinject® is currently registered for use in 45 countries worldwide.

Galenica is a diversified Group active throughout the healthcare market which, among other activities, develops, manufactures and markets pharmaceutical products, runs pharmacies, provides logistical and database services and sets up networks. With its two Business units Vifor Pharma and Galenica Santé, the Galenica Group enjoys a leading position in all its core business activities. A large part of the Group’s income is generated by international operations. Galenica is listed on the Swiss Stock Exchange (SIX Swiss Exchange, GALN, security number 1,553,646).


Christina Hertig

Christina Hertig

Head of Corporate Communications

Galenica Ltd.

Corp. Communications
Untermattweg 8
CH-3027 Bern

+41 58 852 85 17
+41 58 852 85 58

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