FDA CRL - Aft Pharmaceuticals Ltd

The U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) for AFT Pharmaceuticals Ltd.'s New Drug Application (NDA 218528) for sirolimus cream. The FDA determined that the application cannot be approved in its present form due to various deficiencies in product quality, manufacturing facilities, clinical data, and labeling.

Key issues include unresolved product quality concerns regarding the drug product and microbiology. A surveillance inspection of a manufacturing facility identified deficiencies that require satisfactory resolution. Depending on additional data, AFT Pharmaceuticals may need to conduct further clinical trials. The proposed prescribing information and labeling, including carton and container labels, require revisions to comply with FDA regulations (e.g., 21 CFR 201.56, 201.57, 208.24) and guidance.

Additionally, a comprehensive safety update is required per 21 CFR 314.50(d)(5)(vi)(b), mandating detailed safety profile changes, updated adverse event data, case reports for serious events, and worldwide safety experience. The proprietary name, though conditionally acceptable, must be resubmitted after all other deficiencies are addressed. AFT Pharmaceuticals Ltd. must fully resolve these cited issues for the NDA to be reconsidered for approval.