BioCentury
ARTICLE | Clinical News

Northera droxidopa regulatory update

August 19, 2013 7:00 AM UTC

Chelsea said it submitted additional information to FDA regarding technical deficiencies identified in a resubmitted NDA for Northera droxidopa to treat symptomatic neurogenic orthostatic hypotension (NOH). In July, FDA accepted the resubmitted NDA and assigned the application a Jan. 3, 2014, PDUFA date. However, Chelsea said later that month that FDA would delay the PDUFA review for Northera until the biotech addressed the deficiencies (see BioCentury, July 5 & Aug. 5). The application is seeking approval of Northera to treat symptomatic NOH in patients with primary autonomic failure, dopamine beta hydroxylase deficiency and non-diabetic autonomic neuropathy. ...