FDA CRL - GeNO LLC

The U.S. Food and Drug Administration (FDA) issued a Complete Response Letter to GeNO LLC regarding its New Drug Application (NDA 202860) for GENOsyl

(nitric oxide for inhalation), submitted under section 505(b)(2). The agency determined the application could not be approved in its current form due to significant deficiencies primarily in product quality and facility readiness.

Key issues included the lack of sufficient data for determining impurities and setting specifications for the product's cartridges. The FDA found the proposed quality control method for batch release and expiration dating unacceptable, requiring new data and performance correlation. Insufficient long-term and accelerated stability study data from commercial batches were provided to support the proposed expiration period. Furthermore, the application lacked adequate data demonstrating cartridge capacity under simulated conditions and the effectiveness of filters in preventing contamination. The release specifications for the cartridges were deemed inadequate, needing more comprehensive testing for content, stability, and functional effectiveness.

Regarding facility readiness, inspections were attempted at several manufacturing sites, including GeNO LLC's facility (FEI 3010143995), but could not be completed because the sites were not prepared. Another facility's inspection was deferred due to noted deficiencies. GeNO LLC is required to provide extensive product quality data, revised specifications, comprehensive stability protocols, and ensure all manufacturing facilities are ready for satisfactory inspection upon re-submission for the application to be reconsidered.