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 PDUFA date. 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 Extra, Sept. 5).

Actavis -- which gained the nebivolol/valsartan combo through its acquisition of Forest Laboratories Inc. -- was off $1.36 to $231.25 on Wednesday. ...