Nicox: response to CRL from FDA.

(CercleFinance.com) - NicOx has announced that its global exclusive licensed partner has submitted a response to the complete response letter (CRL) received from the US FDA for latanoprostene bunod ophthalmic solution, 0.
024%, for the reduction of intraocular pressure in patients with glaucoma or ocular hypertension.

For the record, Bausch + Lomb, a subsidiary of Valeant, last week received a response letter concerning a BPFA (good practices of current manufacturing) inspection for its factory in Tampa, Florida.

Nicox said that Valeant wishes to work closely with the FDA to determine the next steps to obtain a marketing authorization.


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