BRIEF-Valeant says no safety concerns, additional clinical trials for approval of Latanoprostene Bunod

Fri Jul 22, 2016 2:05am EDT
 
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July 22 (Reuters) - Valeant Pharmaceuticals International Inc

* Concerns raised by fda pertain to good manufacturing practice inspection at bausch+lomb's facility in florida where deficiencies were identified

* Valeant pharmaceuticals receives complete response letter from the fda

* Fda's letter did not identify any efficacy or safety concerns with respect to nda or additional clinical trials needed for approval of nda

* Intends to meet with fda as soon as possible to work on a resolution and address these concerns

* No safety or efficacy concerns or additional clinical trials identified for approval of latanoprostene bunod Source text for Eikon: Further company coverage: (Bengaluru Newsroom +91 80 6749-1130; within U.S. +1 646 223 8780)