FDA delays Northera PDUFA by just over a month

Chelsea Therapeutics International Ltd. (NASDAQ:CHTP) said the new PDUFA date for Northera droxidopa to treat symptomatic neurogenic orthostatic hypotension (NOH) is Feb. 14, 2014, just over a month later than the Jan. 3 PDUFA date the agency had originally assigned. In July, Chelsea said FDA identified undisclosed technical deficiencies with the application, which the company said would delay the PDUFA date. Northera is an orally available synthetic precursor of norepinephrine (see BioCentury Extra, July 17). ...