Nebivolol Approval Could Come Before Extended User Fee Date Of May 31
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Mylan nebivolol user fee date extended to May 31 after submission of additional analyses of already submitted data, firm says. Mylan had planned to use proposed merger partner King’s sales force for the beta blocker before the deal collapsed in eleventh hour. Mylan may seek another partner, but licensor J&J has last call