MGI PHARMA (MOGN) sNDA for Aloxi Capsules Accepted for Review By the FDA
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MGI PHARMA, INC. (Nasdaq: MOGN) and Swiss partner HELSINN HEALTHCARE SA announced that a supplemental New Drug Application for Aloxi Capsules for oral administration was accepted for filing by the FDA.
Under PDUFA (Prescription Drug User Fee Act) III, the FDA's goal is to review and act on the NDA by August 22, 2008.
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