September 22, 2015
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FDA accepts NDA for Vesneo

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The FDA has accepted Bausch + Lomb and Nicox’s new drug application for Vesneo for review, according to a press release from Valeant Pharmaceuticals.

“The acceptance for review of the Vesneo NDA by the FDA marks an important milestone in our effort to bring a new treatment to patients with open angle glaucoma and ocular hypertension,” J. Michael Pearson, CEO and chairman of Valeant, said in the release.

Vesneo (latanoprostene bunod ophthalmic solution 0.024%) is a once-daily IOP-lowering single-agent eye drop for patients with open-angle glaucoma or ocular hypertension.

The FDA has set an action date for July 21, 2016, to complete its review in accordance with the Prescription Drug User Fee Act.