FDA CRL - Scienture Inc.

The FDA issued a Complete Response Letter (CRL) on August 19, 2024, to Scienture Inc. regarding its New Drug Application (NDA 218772) for losartan potassium oral suspension. Filed under section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act, the application cannot be approved in its current form due to significant outstanding deficiencies identified during the review process. The primary issues cited were 'outstanding product quality deficiencies,' which necessitate further assessment of the drug product lots used in critical bioavailability and food effect studies. Additionally, while specific comments on prescribing information, carton, and container labeling were reserved, these sections will require resolution once the application is otherwise approvable. The proposed proprietary name, 'Arbli,' was conditionally accepted but requires resubmission after all other deficiencies are addressed. A crucial required action for Scienture Inc. is to provide a comprehensive safety update, as outlined in 21 CFR 314.50(d)(5)(vi)(b). This update must detail any significant changes in the safety profile, present new clinical safety data, compare adverse event frequencies, and include narrative summaries for deaths or serious adverse events. Scienture Inc. has one year to address all identified deficiencies and resubmit the application as a complete response to initiate a new review cycle.