Dec. 6 – The FDA has sent an approvable letter to Forest Laboratories and Mylan for its new drug application (NDA) for nebivolol (proposed brand name Bystolic), a beta blocker under review for the treatment of hypertension.
In the approvable letter, the FDA indicated that a recent inspection of a backup manufacturing facility in Belgium uncovered deficiencies and that final marketing approval for nebivolol would be contingent upon satisfactory resolution of these deficiencies, Forest and Mylan said.
The approvable letter did not raise any questions related to safety or efficacy of nebivolol, according to the New York City-based Forest and the Pittsburgh-based Mylan. Currently, the companies and the FDA have agreed upon product labeling text.
Howard Solomon, chairman and CEO of Forest, said “We will work expeditiously with the FDA to secure final marketing approval.”