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Bausch + Lomb, Nicox resubmit NDA for latanoprostene bunod

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Bausch + Lomb and Nicox have resubmitted a new drug application to the FDA for approval of latanoprostene bunod ophthalmic solution 0.024% once-daily eye drops, according to a press release.

The FDA previously addressed concerns about the product’s manufacturing facility in Tampa, Florida, which arose during a Current Good Manufacturing Practice inspection.

The IOP-lowering prostaglandin eye drop is for use in patients with open-angle glaucoma or ocular hypertension

Bausch + Lomb licensed the drug from Nicox.