Tris Pharma Inc. – FDA CRL

The U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) to Tris Pharma, Inc. for its New Drug Application (NDA 210526) for Dyanavel XR (amphetamine) extended-release tablets. The application, submitted under section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act, cannot be approved in its current form. Key deficiencies stem from a recent inspection of Tris Pharma’s manufacturing facility, where issues were identified that require satisfactory resolution. Regulatory concerns include the lack of documented receipt for the Paragraph IV certification notice related to U.S. Patent Number 6,384,020, as mandated by 21 CFR 314.52(e). Additionally, several labeling aspects need revision. The proposed prescribing information requires updates to comply with FDA regulations. Carton and container labels must be adjusted to ensure the established name is appropriately sized relative to the proprietary name. Furthermore, the mandatory pharmacist statement, "ATTENTION PHARMACIST: Each patient is required to receive the enclosed Medication Guide," must be added to carton and container labels as per 21 CFR 208.24(d). The previously accepted proprietary name, Dyanavel XR, also needs to be resubmitted. To secure approval, Tris Pharma must resolve all facility deficiencies, provide the necessary Paragraph IV documentation, revise all specified labeling, and resubmit the proprietary name. The company is required to fully address these issues and resubmit the application within one year; failure to do so may lead to its withdrawal. A meeting with the FDA can be requested to discuss the necessary steps.