Valeant Receives Complete Response Letter for Manufacturing
Valeant Pharmaceuticals International has received a second Complete Response Letter (CRL) from the US Food and Drug Administration (FDA) regarding the new drug application (NDA) for its eye-care product, latanoprostene bunod ophthalmic solution, 0.024%.
The solution is an investigative intraocular pressure lowering single-agent eye drop for patients with open-angle glaucoma or ocular hypertension.
The CRL refers to a current good manufacturing practice inspection at Valeant’s Bausch + Lomb’s manufacturing facility in Tampa, Florida. The FDA did not identify any efficacy or safety concerns with respect to the NDA or additional clinical trials needed for the approval of the NDA. Valeant said it will work closely with the FDA to determine the appropriate next steps for the NDA.
The company had earlier received a CRL for the product manufactured at its Tampa facility in 2016.