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conix

11/04/17 5:41 PM

#276175 RE: dr_lowenstein #276173

VRX seemed to have handled their CRL quickly--in two months.

I had a "sit down" with the CEO and I cannot be more enthusiastic about ELTP!. His goal is to hold the record for the longest time it takes to get a CRL lifted. So glad I had that sit down.

FDA OKs Valeant's eye drop latanoprostene bunod after CRL issues addressed

Nov. 2, 2017 4:11 PM ET|About: Valeant Pharmaceutical... (VRX)|By: Douglas W. House, SA News Editor
The FDA has approved Valeant Pharmaceuticals' (NYSE:VRX) Vyzulta (latanoprostene bunod ophthalmic solution) for lowering intraocular pressure in patients with open-angle glaucoma or ocular hypertension.
The company received a CRL in August in response to its original filing citing CGMP issues at a Bausch + Lomb manufacturing facility in Tampa, FL.