ARTICLE | Clinical News
Valeant expects to resolve manufacturing issues after second Vyzulta CRL
August 18, 2017 8:02 PM UTC
Valeant Pharmaceuticals International Inc. (TSX:VRX; NYSE:VRX) said that the CGMP inspection issues identified at its Bausch + Lomb manufacturing facility in Tampa, Fla., will soon be “satisfactorily resolved.”
Earlier this month, Valeant received a second complete response letter from FDA for Vyzulta latanoprostene bunod to reduce intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. Valeant said the CRL cited CGMP inspection issues at the Tampa facility and did not identify any safety or efficacy concerns (see BioCentury, Aug. 14)...
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