August 7, 2017 / 9:09 PM / in 4 months

BRIEF-Valeant Pharmaceuticals receives complete response letter for Latanoprostene Bunod Ophthalmic Solution

Aug 7 (Reuters) - Valeant Pharmaceuticals International Inc

* Valeant Pharmaceuticals receives complete response letter from the FDA for Latanoprostene Bunod Ophthalmic Solution, 0.024 pct NDA

* ‍CRL from FDA refers to a current good manufacturing practice (CGMP) inspection at Bausch + Lomb’s manufacturing facility in Tampa, FLA​

* ‍FDA did not identify efficacy,safety concerns with respect to nda for Latanoprostene Bunod Ophthalmic Solution, 0.024 pct​

* ‍FDA did not identify additional clinical trials needed for approval of NDA for Latanoprostene Bunod Ophthalmic Solution, 0.024 pct​ Source text for Eikon: Further company coverage:

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