FDA CRL - Teva Pharmaceuticals USA Inc

The U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) to Teva Pharmaceuticals USA for its New Drug Application (NDA 208042) for buprenorphine and naloxone sublingual film, 16 mg/4 mg. The application, submitted under section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act, cannot be approved in its current form due to several deficiencies. The primary issue cited was the inability to complete an inspection of the Lohmann Therapy Systems manufacturing facility in West Caldwell, New Jersey, as the site was not ready, which is a mandatory prerequisite for approval.

Further issues include requirements for the proposed prescribing information and labeling. Teva must revise the labeling to conform with current FDA regulations, including the PLR Requirements and the Pregnancy and Lactation Labeling Final Rule. Specifically, the product name and strengths across all labeling must consistently use the active base form, accompanied by an equivalency statement to the salt form, adhering to the USP salt policy. Additionally, carton and container labels require a bolded statement instructing pharmacists that each patient must receive the enclosed Medication Guide, as per 21 CFR 208.24(d).

While the FDA acknowledges Teva's proposed Risk Evaluation and Mitigation Strategy (REMS), further discussions will occur once other deficiencies are addressed. Teva is also required to submit a comprehensive safety update with its resubmission, detailing any significant changes in the safety profile, updated clinical trial data, and worldwide experience, in accordance with 21 CFR 314.50(d)(5)(vi)(b).

To proceed, Teva must notify the FDA when the manufacturing facility is ready for inspection, address all labeling and Medication Guide issues, provide the required safety update, and submit a complete response within one year.