Chelsea Therapeutics, Inc. (CHTP) Announces FDA Acceptance of NORTHERA (droxidopa) NDA Resubmission
9/5/2013 9:56:58 AM
CHARLOTTE, N.C., Sept. 4, 2013 (GLOBE NEWSWIRE) -- Chelsea Therapeutics International, Ltd. (Nasdaq:CHTP) today announced that the U.S. Food and Drug Administration (FDA) has acknowledged receipt of the New Drug Application (NDA) resubmission seeking approval to market NORTHERA™ (droxidopa), an orally active synthetic precursor of norepinephrine, for the treatment of symptomatic neurogenic orthostatic hypotension (NOH). The resubmission includes additional information to resolve certain technical deficiencies previously noted by the Agency. The FDA has deemed the current resubmission a complete response to its March 28, 2012 Complete Response Letter and assigned a new Prescription Drug User Fee Act (PDUFA) goal date of February 14, 2014.
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