FDA CRL - Lannett Holdings, Inc.

The FDA issued a Complete Response Letter (CRL) to Lannett Holdings, Inc. regarding its New Drug Application (NDA 209575) for Cocaine Hydrochloride Topical Solution, 4% and 10%. Submitted under section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act, the application was not approved due to several deficiencies.Clinically, the agency requires a thorough QT study to adequately characterize the product's effects on the QT interval. Nonclinically, the FDA identified an inadequate leachables evaluation for the proposed container closure system. This necessitates a new leachables study across multiple batches and timepoints under standard storage conditions, a toxicological assessment for any leachables exceeding 5 mcg/day, and a discussion of extractables-leachables correlation. Additionally, several nonclinical study reports lacked test article purity information and require revision.Regarding regulatory matters, the draft labeling inappropriately cited non-US conclusions without adequate justification or adherence to 505(b)(2) requirements for relying on listed drugs, such as appropriate patent certifications or bridging data. Lannett must submit revised labeling with appropriate sources. The agency also mandates a comprehensive safety update as per 21 CFR 314.50(d)(5)(vi)(b), including new safety data, retabulations, case reports for serious adverse events, and worldwide safety experience. A resubmission of the proprietary name "NUMBRINO" is also required. Lannett must fully address all identified deficiencies for reconsideration within one year.