FDA Issues Approvable Letter to Mylan for Nebivolol

The FDA has deemed Mylan Laboratories' beta-blocker nebivolol "approvable" pending successful completion of a preclinical study and finalization of the drug's labeling, Mylan said.

The agency issued Mylan an approvable letter for nebivolol outlining additional requirements regarding preclinical data and labeling information. The company provided few details about the FDA's request, saying only that it is currently conducting a preclinical study to address the agency's concerns.

"We believe that the data from the ongoing preclinical study will satisfactorily resolve the FDA's questions," Mylan Chief Scientific Officer John O'Donnell said. "We will be responding to the FDA in an expeditious manner to move forward with the hypertension approval process."

The FDA was supposed to issue a decision on nebivolol Feb. 28, but the agency delayed the Prescription Drug User Fee Act action date until May 31 to review additional data on the drug. The FDA's latest request will delay the user-fee date by up to three months.