Chelsea Therapeutics Issues Statement Regarding Postponement of NORTHERA(TM) (Droxidopa) NDA PDUFA Action Date Due to Severe Weather
CHARLOTTE, N.C., Feb. 14, 2014 (GLOBE NEWSWIRE) — Chelsea Therapeutics International, Ltd. (Nasdaq:CHTP) today issued the following statement regarding the U.S. Food and Drug Administration (FDA) Prescription Drug User Fee Act (PDUFA) action date for the Company’s NORTHERAâ„¢ (droxidopa) New Drug Application (NDA):
“As a result of severe weather conditions leading to an office closure, FDA today notified Chelsea Therapeutics that the goal date for the Company’s NORTHERA NDA has been extended to the next business day, or Tuesday, February 18, 2014.”
no apto para cardiacos
CHTP