FDA CRL - SQ Innovation, Inc

SQ Innovation, Inc. received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) dated January 12, 2024, regarding its New Drug Application (NDA 217294) for furosemide injection for subcutaneous use. The FDA determined that the application cannot be approved in its current form due to several deficiencies identified during the review. Key issues include concerns related to Product Quality, requiring specific details to be addressed, and deficiencies in the Prescribing Information. The latter involves revisions to the draft labeling, carton and container labeling, and the resubmission of the proposed proprietary name. Furthermore, a comprehensive Safety Update is a critical requirement. This update must incorporate all new nonclinical and clinical study data, detail significant changes in the safety profile, present combined and comparative adverse event frequencies, retabulate trial discontinuations, provide case report forms and narrative summaries for deaths or adverse event-related discontinuations, describe changes in common adverse events, update exposure information, and summarize worldwide safety experience, including English translations of foreign labeling. While not a reason for non-approval, the FDA also recommended that SQ Innovation consider the impact of any product revisions on its user interface and human factors. To proceed, SQ Innovation is required to fully address all deficiencies outlined in the CRL and resubmit the application within one year. The company may also request a meeting with the FDA to discuss the necessary steps for approval. The product cannot be legally marketed until written approval is received from the FDA.