Final approval of nebivolol is contingent upon successfully satisfying additional FDA requirements regarding certain aspects of the preclinical data and finalization of the labeling.
The preclinical data submitted in the new drug application (NDA) was based upon studies previously conducted by Janssen Pharmaceutica NV Belgium (currently Johnson & Johnson Pharmaceutical R&D Beerse), the company from whom Mylan licensed the product.
Currently Mylan is conducting a preclinical study designed to address questions posed by the FDA. “We believe that the data from the ongoing preclinical study will satisfactorily resolve the FDA’s questions,” said Dr John O’Donnell, chief scientific officer for Mylan Laboratories. “We will be responding to the FDA in an expeditious manner to move forward with the hypertension approval process.”
In separate news, it has been revealed that financier Carl Icahn is again proposing to acquire Mylan Laboratories, for more than $5 billion. In a letter to Mylan, Icahn also said that he and his High River LP affiliate considered it fortunate that Mylan did not carry out its proposed acquisition of King Pharmaceutical.