| Galenica: FDA assigns PDUFA Date for Injectafer NDA |
| 15.12.11 07:08 | |
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Galenica announced in October 2011 that its US partner Luitpold Pharmaceuticals, Inc., had submitted a New Drug Application (NDA) with the US Food and Drug Administration (FDA) for Injectafer® (US brand name of Ferinject®, ferric carboxymaltose) for the treatment of iron deficiency anaemia. Galenica today announces that the FDA has notified Luitpold Pharmaceuticals, Inc., that it has assigned a Prescription Drug User Fee Act (PDUFA) target action date of 3 August 2012. The FDA has assigned 3 August 2012 as the Prescription Drug User Fee Act (PDUFA) target action date to complete its review of the New Drug Application (NDA) for Injectafer® for the treatment of iron deficiency anaemia. The PDUFA action date is a target date for the FDA to complete its review. The FDA could respond sooner or extend the action date as the review and discussions progress. For more information, click here Galenica is a diversified group active throughout the healthcare market which, among other things, develops, manufactures, markets and distributes pharmaceutical products, runs pharmacies, provides logistical and database services and sets up networks. In all of its business sectors – Pharma, Logistics and Retail – the Galenica Group enjoys a leading position. 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). For more information please visit the company’s website at www.galenica.com. |
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