Valeant Receives CRL Due to GMP Inadequacies

Valeant Pharmaceuticals’ application for a latanoprostene bunod eye solution was rejected by the FDA amid concerns about conditions at the company’s manufacturing facilities.

An agency inspection of Valeant’s Bausch + Lomb’s facility in Tampa, Fla., uncovered GMP deficiencies unrelated to efficacy and safety concerns, the company said.

The eye drops are intended to reduce intraocular pressure in patients with angle glaucoma or ocular hypertension.