FDA CRL - Valeant Pharmaceuticals Ireland

The U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) to Valeant Pharmaceuticals Ireland concerning its New Drug Application (NDA 210821) for tetracaine hydrochloride ophthalmic solution, 0.5%. The primary issue preventing approval was identified during a recent inspection of the Bausch & Lomb Inc. manufacturing facility. FDA investigators observed practices that were not consistent with current good manufacturing practice (cGMP) regulations, as outlined in 21 CFR 210 and 211. Compliance with these regulations is mandatory for all facilities involved in the manufacture, processing, packing, or holding of drug substances or products. To address these deficiencies, Valeant must ensure the manufacturing facility fully complies with cGMP standards. Furthermore, the company is required to review and revise its proposed product labeling to align with FDA's Prescribing Information (PLR) requirements and the Pregnancy and Lactation Labeling Final Rule, submitting a revised package insert and draft carton/container labeling. A safety update, as per 21 CFR 314.50(d)(5)(vi)(b), must accompany any resubmission. Valeant has one year to resubmit the application, which should clearly indicate it is a complete response addressing all noted deficiencies. The FDA also offers the option to request a meeting to discuss the required steps for approval.