FDA CRL - CMP DEVELOPMENT LLC

The U.S. Food and Drug Administration issued a Complete Response Letter (CRL) to CMP Development LLC for its New Drug Application (NDA 214522) for TADLIQ (Tadalafil) Oral Suspension, 4 mg/ml. The FDA determined the application cannot be approved in its current form, primarily due to significant product quality concerns related to manufacturing facilities. Objectionable conditions were identified during a review of company records, and deficiencies were noted during a recent inspection of a manufacturing facility. Satisfactory resolution of these facility issues, which may include a preapproval inspection and/or adequate responses from the facility, is required before approval.

Further comments on the proposed prescribing information (labeling) are reserved until other deficiencies are addressed. While the proprietary name, TADLIQ, was deemed acceptable, it must be resubmitted with the revised application. The company is also required to provide a comprehensive safety update, adhering to specific guidelines outlined in 21 CFR 314.50(d)(5)(vi)(b), detailing any changes in the safety profile, updated adverse event data, and worldwide experience. Additionally, specific in-process controls for the drug product need to be included. CMP Development LLC has one year to resubmit the application, fully addressing all identified deficiencies, to avoid potential withdrawal under 21 CFR 314.65.