Shanghai xuanmei biological science and Technology Co., Ltd. – FDA CRL

The U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter to Shanghai Auzone Biological Technology Co., Ltd. regarding its New Drug Application for Edaravone. The agency concluded that the application cannot be approved in its current form, citing deficiencies related to nonclinical data and product quality. While specific inspection dates were not detailed in the provided correspondence, the FDA highlighted several critical areas for improvement under the regulatory framework of 21 CFR 314.110. Key issues identified include inadequate prescribing information and container labeling, alongside the requirement for a comprehensive safety update. This update must consolidate data from all clinical and nonclinical trials, providing detailed accounts of serious adverse events, patient deaths, and trial discontinuations. Additionally, the company must resubmit its proposed proprietary name for final approval during the next review cycle. To address these findings, the applicant is required to submit a complete response within one year that fully resolves all listed deficiencies. The FDA emphasizes that a partial response will not be accepted. The company may also request a formal meeting to discuss the specific steps needed to achieve regulatory approval.