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Valeant receives complete response letter from FDA on glaucoma drug

pharmafile | July 22, 2016 | News story | Medical Communications, Sales and Marketing |  FDA, Glaucoma, Valeant 

Valeant Pharmaceuticals has announced that it has received a complete response letter from the FDA rejecting their new drug application for latanoprostene bunod ophthalmic solution, an intraocular pressure lowering single-agent eye drop for patients with open angle glaucoma or ocular hypertension.

The FDA raised concerns around the treatment, developed by Valeant subsidiary Bausch + Lomb, after some deficiencies in current good manufacturing practice were identified during an inspection at their facility in Tampa, Florida.

Valeant indicates that, in the FDA’s letter, no efficacy or safety concerns were identified, nor were any more clinical trials needed, for the approval of the new drug application for latanoprostene bunod ophthalmic solution.

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The company will now meet with the regulator to address these concerns and find a way to work out a resolution.

Sean Murray

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