BRIEF-FDA to inspect Nicox partner Bausch + Lomb
July 22 (Reuters) - Nicox SA :
* Has been informed by its partner Bausch + Lomb, a Valeant unit, of receipt of a complete response letter from U.S. FDA concerning latanoprostene bunod
* FDA's letter did not identify any efficacy or safety concerns with respect to NDA or additional clinical trials needed for approval of NDA for latanoprostene bunod ophthalmic solution, 0.024 pct
* Concerns raised by the FDA pertain to a Current Good Manufacturing Practice (CGMP) inspection at Bausch + Lomb's manufacturing facility in Tampa, Florida
* Some deficiencies were identified by the FDA at the Tampa plant
* Valeant intends to meet with FDA as soon as possible to work on a resolution and address these concerns Source text for Eikon: Further company coverage: (Gdynia Newsroom)
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