New PDUFA action date announced by the US FDA for Injectafer® New Drug Application
Monday, 8 April 2013, ↓ directly to download
Vifor Pharma today announced that its US partner, Luitpold Pharmaceuticals, Inc., has receivedconfirmation 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 European Union. Ferinject® is currently registered for use in 45 countries worldwide.
Vifor Pharma, a company of the Galenica Group, is a world leader in the discovery, development, manufacturing and marketing of pharmaceutical products for the treatment of iron deficiency. The company also offers a diversified portfolio of prescription medicines as well as over-the-counter (OTC) products. Vifor Pharma, headquartered in Zurich, Switzerland, has an increasingly global presence and a broad network of affiliates and partners around the world.
Luitpold Pharmaceuticals, Inc., a Daiichi Sankyo Group Company, headquartered in Shirley, NY, US, manufactures over 80 pharmaceutical products including Venofer® (iron sucrose injection, USP), which are distributed through its human health subsidiary, American Regent, Inc.
For more information on Luitpold or any of its divisions and products, please visit: www.luitpold.com
Injectafer® (US brand name of Ferinject®) is an innovative non-dextran intravenous (i.v.) iron replacement therapy discovered and developed by Vifor Pharma, a company of the Galenica Group. Ferric carboxymaltose is the active pharmaceutical ingredient of Ferinject®. To date, Ferinject® (brand name of Injectafer® outside the US) has gained marketing authorisation in 45 countries worldwide for the treatment of iron deficiency where oral iron is ineffective or cannot be used. In many countries, intravenous iron replacement products are primarily used to treat dialysis patients. However, iron deficiency is also a complication of many other illnesses. Vifor Pharma is evaluating new opportunities in the treatment of iron deficiency with Ferinject® in different therapeutic areas. Further clinical trials with Ferinject® in chronic kidney disease (CKD), oncology (anaemia in cancer patients), cardiology (chronic heart failure), patient blood management and women’s health are ongoing.
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