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FDA raises concerns about manufacturing facility in latanoprostene bunod complete response letter to Valeant
Valeant received a complete response letter from the FDA regarding the new drug application for latanoprostene bunod ophthalmic solution 0.024%, a once-daily topical eye drop for patients with open-angle glaucoma or ocular hypertension, according to a press release. The letter addresses the FDA’s concerns about a Current Good Manufacturing Practice inspection at Bausch + Lomb’s manufacturing facility in Tampa, Florida, where the FDA identified some deficiencies.