Valeant Pharmaceuticals International, Inc.'s (NYSE: VRX and TSX: VRX) wholly owned subsidiary, Bausch + Lomb, and Nicox S.A. (Euronext Paris: FR0013018124, COX) today announced that the U.S. Food and Drug Administration (FDA) has set a PDUFA date of August 24, 2017 for its decision on the New Drug Application (NDA) for latanoprostene bunod ophthalmic solution, 0.024%. Latanoprostene bunod is an intraocular pressure (IOP) lowering single-agent eye drop dosed once daily, for patients with open angle glaucoma (OAG) or ocular hypertension (OHT).
Nicox’s new drug application for AC-170, its eye drop for treating itchiness associated with allergic conjunctivitis, hit a setback after the Food and Drug Administration said it has issues with a contracted facility which supplies the manufacturer of the finished drug, the company revealed Monday.
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