FDA CRL - Liqmeds Worldwide Limited

The FDA issued a Complete Response Letter (CRL) on January 6, 2023, to Liqmeds Worldwide Limited regarding its New Drug Application (NDA 216482) for mycophenolate mofetil oral suspension. The FDA cannot approve the application in its current form, primarily due to the absence of a required Risk Evaluation and Mitigation Strategy (REMS). This deficiency stems from the FDA's determination, communicated on June 22 and October 17, 2022, that a REMS is necessary under Section 505-1 of the Federal Food, Drug, and Cosmetic Act (FDCA) to mitigate risks of first-trimester pregnancy loss and congenital malformations.Required actions for Liqmeds include: developing and submitting a comprehensive REMS proposal, providing the REMS document in Structured Product Labeling (SPL) format, updating the prescribing information to align with regulatory guidances, resubmitting the proposed proprietary name, and delivering a detailed safety update. This safety update must encompass all nonclinical and clinical data, including worldwide experience and English translations of any foreign labeling. Liqmeds has one year to resubmit a complete response addressing all identified deficiencies, as a partial response will not initiate a new review cycle.