re: Ann: Pharmaxis Submits US New Drug Applic... I would anticipate FDA approval by Christmas at the latest thanks to the Prescription Drug User Fee Act. PDUFA dates are deadlines for the FDA to approve new drug. The FDA is normally given 10 months to review new drugs. If a drug is selected for priority review then 6 months is allotted. These times begin from the date a NDA is submitted.
Ann: Pharmaxis Submits US New Drug Application fo, page-2
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