The firm announced the receipt of the complete response letter (CRL) from the US Food and Drug Administration (FDA) regarding its latanoprostene bunod ophthalmic solution new drug application (NDA) – an investigative intraocular pressure lowering single-agent eye drop for patients with open angle glaucoma or ocular hypertension.
“The CRL from the FDA only refers to current good manufacturing practice (cGMP) inspection at Gausch + Lomb’s manufacturing facility in Tampa, Florida, US,” the firm said yesterday.
“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 for latanoprostene bunod ophthalmic solution, 0.024%.”
Valeant said it will work with the FDA to establish the relevant next steps for the NDA.
In July last year, Valeant announced it received a CRL from the FDA for the same ophthalmic candidate, again citing cGMP issues at Bausch + Lomb’s Tampa, Florida-based facility.
The firm did not respond to questions regarding specific cGMP issues before the time of publishing.