FDA CRL - POLAREAN INC

The U.S. Food and Drug Administration issued a Complete Response Letter (CRL) to Polarean Inc. for its New Drug Application (NDA 214375) for Xenoview (xenon-129 hyperpolarized) for Inhalation, submitted under section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act. The agency identified several deficiencies related to product quality, device design, reliability, and manufacturing. Polarean failed to establish adequate specifications and acceptance limits for xenon-129 polarization, a critical quality attribute, and did not validate the production method using commercial equipment under Good Manufacturing Practices (cGMP), citing 21 CFR Part 4 and Part 820. A clear drug product strength was also not proposed.

Regarding the associated device, the FDA noted a lack of final approval and release procedures, insufficient documentation and verification data for Hyperpolarizer design changes, and missing reliability assessment reports for the Hyperpolarizer and Quality Control Measurement system. Facility inspections revealed deficiencies at Polarean's manufacturing site and other relevant facilities, which require resolution. To secure approval, Polarean must establish robust specifications, validate production processes, define drug product strength, provide comprehensive device documentation including reliability reports, address all manufacturing facility issues, and submit a detailed safety update along with updated product labeling.