Valeant Eye Drop Approval Held Up Over Manufacturing Concerns Following FDA Inspection
Federal regulators have expressed concerns over the manufacturing process used to create eye drops at Valeant’s Florida-based Bausch + Lomb facility.
Valeant Pharmaceuticals issued a press release on July 22, announcing that it has received a Complete Response Letter (CRL) from the FDA regarding a New Drug Application (NDA) it submitted to the agency over one of its eye drop products.
The CRL warned that an FDA inspection of the Bausch + Lomb manufacturing facility revealed deficiencies in its Current Good Manufacturing Practices (CGMPs). However, Valeant does not indicate what those problems were, and the letter has not yet been made available to the public.
The company is seeking FDA approval of new eye drops which are a 0.024% latanoprostene bunod ophthalmic solution, designed to lower intraocular pressure for patients with open angle glaucoma or ocular hypertension.
“The FDA’s letter 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, o.o24%,” the press release notes. “Valeant intends to meet with the FDA as soon as possible to work on a resolution and address these concerns.”
The letter comes as Valeant faces an investigation for price gouging and public, as well as congressional, ridicule for perceived inflated drug prices. As a result, it’s shares have dropped more than 80% since the beginning of the year. Valeant’s stock prices fell another 6% following reports of the letter.
The company will likely have to address the FDA’s concerns before it receives approval for the eye drops.