Nicox: response letter from FDA on Latanoprostene Bunod.
(CercleFinance.com) - NicOx has announced that its partner Bausch + Lomb, a subsidiary of Valeant, has received a response letter from the FDA for latanoprostene bunod, 0.
024%, monotherapy eye drops, which are in development phase, to reduce intraocular pressure.
The FDA response letter only concerns a BPFA inspection (current good manufacturing practices) of Bausch + Lomb's manufacturing plant in Tampa, Florida.
The FDA letter makes no reference to any comment about the efficacy or safety of the ophthalmic solution for the application for its marketing and no additional clinical studies are required for its marketing authorisation.
Copyright (c) 2017 CercleFinance.com. All rights reserved.
024%, monotherapy eye drops, which are in development phase, to reduce intraocular pressure.
The FDA response letter only concerns a BPFA inspection (current good manufacturing practices) of Bausch + Lomb's manufacturing plant in Tampa, Florida.
The FDA letter makes no reference to any comment about the efficacy or safety of the ophthalmic solution for the application for its marketing and no additional clinical studies are required for its marketing authorisation.
Copyright (c) 2017 CercleFinance.com. All rights reserved.