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). ...