ARTICLE | Clinical News

Northera droxidopa regulatory update

January 20, 2014 8:00 AM UTC

FDA's Cardiovascular and Renal Drugs Advisory Committee voted 16-1 that the agency should approve an NDA from Chelsea for Northera droxidopa to treat symptomatic neurogenic orthostatic hypotension (NOH). The PDUFA date is Feb. 14. The vote came despite briefing documents in which an FDA reviewer recommended a complete response letter for the orally available synthetic precursor of norepinephrine because there is "inadequate evidence of effectiveness." Chelsea said if approved, the company plans to launch Northera within 6 months of approval. ...