FDA CRL - Novitium Pharma LLC

Novitium Pharma LLC received a Complete Response Letter from the U.S. Food and Drug Administration (FDA) regarding its New Drug Application (NDA 214581) for Hydroxychloroquine Sulfate Tablets. The FDA determined it could not approve the application in its present form, primarily due to significant drug product quality issues, specifically biopharmaceutics deficiencies. To address these, Novitium Pharma must either provide additional specific information or conduct appropriate in vivo bioavailability or bioequivalence studies to establish a bridge to the listed drug, as outlined under the Federal Food, Drug, and Cosmetic Act, Section 505(b)(2).

Beyond these core quality concerns, the FDA also requires a comprehensive safety update, encompassing all nonclinical and clinical study data, including detailed descriptions of any significant changes, re-tabulated adverse event frequencies, and worldwide safety experience. Additionally, the company is instructed to revise the proposed prescribing information to meet current regulatory standards, although this is not the primary reason for non-approval. Novitium Pharma has one year to resubmit a complete response, fully addressing all identified deficiencies, to restart the application review process.