Valeant Receives FDA Complete Response Letter for Eye-Care Drug Over Manufacturing Issues
Valeant Pharmaceuticals International has received a Complete Response Letter (CRL) from the US Food and Drug Administration (FDA) for its new drug application (NDA) for latanoprostene bunod ophthalmic solution, 0.024%, a single-agent eye drop for open angle glaucoma or ocular hypertension. The FDA raised concerns about a cGMP inspection at Bausch + Lomb’s manufacturing facility in Tampa, Florida where the agency identified some deficiencies.
The CRL did not identify efficacy or safety concerns with respect to the NDA or additional clinical trials needed for approval. Valeant said it intends to meet with the FDA to resolve the agency's concerns.