Chelsea Therapeutics, Inc. (CHTP) Announces Submission of Additional Information for NORTHERA (Droxidopa) NDA
8/14/2013 8:25:04 AM
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CHARLOTTE, N.C., Aug. 14, 2013 (GLOBE NEWSWIRE) -- Chelsea Therapeutics International, Ltd. (Nasdaq:CHTP) today announced that it has submitted additional information to the U.S. Food and Drug Administration (FDA) to resolve certain technical deficiencies in the Company's resubmitted New Drug Application (NDA) for NORTHERA™ (droxidopa). Pending confirmation by the FDA, the resubmission is expected to be deemed a complete response to the March 28, 2012 Complete Response Letter (CRL) issued by the Agency. A new six month review clock, as specified under the Prescription Drug User Fee Act (PDUFA), will be set from the date of receipt.
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