BioCentury
ARTICLE | Company News

FDA postpones Northera decision

February 15, 2014 1:18 AM UTC

Chelsea Therapeutics International Ltd. (NASDAQ:CHTP) said late Friday that FDA delayed by one business day the PDUFA date for an NDA for Northera droxidopa to treat symptomatic neurogenic orthostatic hypotension (NOH). A decision was expected Friday, but the agency delayed a decision until Tuesday, Feb. 18. According to the company, the agency delayed the decision due to "severe weather conditions leading to an office closure."

Last month, FDA's Cardiovascular and Renal Drugs Advisory Committee voted 16-1 that the agency should approve Northera for NOH; an FDA reviewer had recommended a complete response letter for the orally available synthetic precursor of norepinephrine (see BioCentury, Jan. 20). ...