FDA Advisory votes against approving Actavis nebivolol/valsartan combo

Ireland-based generic drug major Actavis (NYSE: ACT) yesterday confirmed that the US Food and Drug Administration's Cardiovascular and Renal Drugs Advisory Committee (CRDAC) has voted by six to four to not recommend approval of Actavis' New Drug Application for the fixed-dose combination of nebivolol and valsartan for the treatment of hypertension.

The committee recommendation is not binding on the FDA, which makes the final decision regarding approval. Actavis expects FDA action on its NDA for the fixed-dose combination of nebivolol and valsartan by the fourth quarter of 2014.

"Although we are disappointed in the Committee's recommendation regarding the fixed-dose combination of nebivolol and valsartan, we remain fully committed to supporting the NDA for this important potential new treatment option for patients with hypertension," said David Nicholson, senior vice president, Global Brands R&D, Actavis, adding: "We remain confident in the safety and efficacy of the combination of these two widely used and well-tolerated treatments, and we look forward to working with the FDA as it completes its review."