ARTICLE | Clinical News

Nebivolol/valsartan regulatory update

January 5, 2015 8:00 AM UTC

FDA issued a complete response letter to Actavis for its fixed-dose combination of nebivolol and valsartan to treat hypertension. The company said it will review the letter and determine next steps. Last September, FDA’s Cardiovascular and Renal Drugs Advisory Committee voted 6-4 against approval of the NDA. In briefing documents released ahead of the meeting, FDA reviewers questioned whether the combo provides a “clinically meaningful” benefit in patients with hypertension (see BioCentury, Sept. 15, 2014). ...