FDA rejects Valeant's marketing application for IOP eye drop latanoprostene bunod

|By:, SA News Editor

The FDA issues a Complete Response Letter (CRL) to Valeant Pharmaceuticals (NYSE:VRX) related to its New Drug Application (NDA) seeking approval for latanoprostene bunod ophthalmic solution, 0.024% for lowering intraocular pressure (IOP) in patients with open angle glaucoma or ocular hypertension.

The CRL cited Current Good Manufacturing Practice (CGMP) issues observed during an on-site inspection at subsidiary Bausch + Lomb's manufacturing facility in Tampa, FL. No efficacy or safety concerns with the product were mentioned.

The company says it will work with the agency to address the matter.

Shares are off a fraction premarket.

Subscribe for full text news in your inbox