Meitheal Pharmaceuticals, Inc – FDA CRL

The FDA issued a Complete Response Letter (CRL) to Meitheal Pharmaceuticals Inc. regarding its New Drug Application (NDA 212271) for fosfomycin for injection. The primary reason for non-approval is significant deficiencies identified during a pre-approval inspection of a manufacturing facility listed in the application. These issues, documented in an FDA Form 483, were deemed to adversely impact the facility's ability to perform its designated functions, and their satisfactory resolution is a prerequisite for approval.The FDA also noted outstanding comments on the proposed prescribing information, carton, and container labeling, requiring revisions to align with regulatory guidance and submission in structured product labeling (SPL) format. The proprietary name, previously found conditionally acceptable, must be resubmitted once all other deficiencies are addressed. Additionally, Meitheal Pharmaceuticals is required to provide a comprehensive safety update, including detailed changes in the safety profile, updated adverse event tabulations, revised reasons for trial discontinuations, case report forms for deaths and serious adverse events, and a summary of worldwide safety experience.Meitheal Pharmaceuticals must address all identified deficiencies and resubmit the application as a complete response within one year. Failure to do so may result in the application's withdrawal. The product cannot be legally marketed until formal approval is granted.