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Astellas Announces the Extension of US Regulatory Review for the sNDA of MYCAMINE |
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04 Sep 2007 |
Astellas pharma announced that its subsidiary, Astellas Pharma US has received notification from FDA that the action date under the Prescription Drug User Fee Act (PDUFA) for the supplemental New Drug Application (sNDA) seeking approval for the use of its achinocandin MYCAMINE (micafungin sodium) for injection in the treatment of candidemia and other Candida infections has been extended by three months in order to allow sufficient time to review additional information recently submitted by Astellas US in response to FDA requests.
http://www.astellas.com/global/about/news/2007/pdf/070903_eg.pdf |
