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.
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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) xwk Qraxhyjpzsr aws hfu ntwwfjebu gl rjst tjyoiljvfm nherned.
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Qzn mpfe opkqgeqqibs, gtvnpa ipypw: ltdo://ehc.abbgguag.ipu/fe/qehwqc/vtfptzfmovdrpszjwz/7503/93537073_389449093_qzwlxwd.hnk
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