FDA CRL - Rosemont Pharmaceuticals Holdings, Inc.

The U.S. Food and Drug Administration (FDA) issued a Complete Response Letter to Rosemont Pharmaceuticals Holdings, Inc. on March 5, 2026, regarding its New Drug Application (NDA 220140) for valacyclovir oral suspension. The FDA determined that the application cannot be approved in its current form due to unresolved facility and safety documentation issues.

The primary concern involves manufacturing standards. Following a recent inspection, the FDA identified deficiencies at a listed facility, resulting in the issuance of a Form 483. Approval is contingent upon the facility returning to full compliance with Current Good Manufacturing Practices (CGMP), which may necessitate a follow-up Pre-approval inspection. Additionally, the company must provide a comprehensive safety update as required by regulatory framework 21 CFR 314.50. This update must include consolidated data from all clinical and nonclinical trials, detailed reports on adverse events, and a summary of worldwide safety experience.

To proceed, Rosemont Pharmaceuticals must submit a complete resubmission within one year that fully addresses all identified deficiencies. This response must include the dates of the facility's corrective actions and a formal resubmission of the proposed proprietary name, which remains only conditionally accepted. The FDA noted that a partial response will not be reviewed and the drug cannot be legally marketed until a formal approval is granted.