08:00 , Jan 5, 2015 |  BC Week In Review  |  Clinical News

Nebivolol/valsartan regulatory update

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...
07:00 , Sep 15, 2014 |  BC Week In Review  |  Clinical News

Nebivolol/valsartan regulatory update

FDA's Cardiovascular and Renal Drugs advisory committee voted 6-4 against approval of an NDA from Actavis for a fixed-dose combination of nebivolol and valsartan to treat hypertension. The product has a Dec. 24 PDUFA date....
02:32 , Sep 11, 2014 |  BC Extra  |  Company News

FDA panel rebuffs Actavis' nebivolol/valsartan

FDA's Cardiovascular and Renal Drugs advisory committee voted 6-4 against approval of an NDA from Actavis plc (NYSE:ACT) for a fixed-dose combination of nebivolol and valsartan to treat hypertension. The product has a Dec. 24...
01:21 , Sep 6, 2014 |  BC Extra  |  Company News

FDA reviewers question nebivolol/valsartan benefit

FDA reviewers questioned whether a fixed-dose combination of nebivolol and valsartan from Actavis plc (NYSE:ACT) provides a "clinically meaningful" benefit in patients with hypertension. The reviewers noted the combo led to a greater reduction in...
08:00 , Mar 3, 2014 |  BC Week In Review  |  Clinical News

Nebivolol/valsartan regulatory update

Forest submitted an NDA to FDA for a fixed-dose combination of nebivolol and valsartan to treat hypertension. Forest said the application was based on a double-blind pivotal trial in 4,161 hypertensive patients that compared fixed...