CHARLOTTE, N.C., July 29, 2013 (GLOBE NEWSWIRE) -- Chelsea Therapeutics International, Ltd. (Nasdaq:CHTP) today announced that the U.S. Food and Drug Administration (FDA), upon further review of the Company's resubmitted New Drug Application (NDA) for NORTHERA™ (droxidopa), has identified certain technical deficiencies in the resubmission that will require resolution prior to the resubmission being deemed a complete response. As previously announced on July 17, 2013, Chelsea had received written confirmation from the FDA that the resubmission was deemed to be a complete response to its March 28, 2012 Complete Response Letter and was assigned a new PDUFA date of January 3, 2014.
Chelsea Therapeutics Announces Update To NORTHERA(TM) (Droxidopa) NDA Filing
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