FDA CRL - Supernus Pharmaceuticals, Inc.

Supernus Pharmaceuticals, Inc. received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding its New Drug Application (NDA 211964) for viloxazine hydrochloride extended-release capsules. The FDA determined the application cannot be approved in its present form, citing multiple deficiencies under the Federal Food, Drug, and Cosmetic Act and related regulations. A primary concern involves objectionable conditions identified at Supernus' manufacturing facility, discovered during a review of records. Resolution of these conditions, potentially requiring a preapproval inspection or comprehensive responses from the facility, is mandatory before the application can proceed. Further issues relate to the proposed labeling. The carton and container labeling was found unacceptable from a Chemistry, Manufacturing, and Controls standpoint, specifically regarding the declared drug substance content, necessitating revision. Additionally, Supernus must add a required statement concerning the Medication Guide to all relevant labels. While the proprietary name "Qelbree" was deemed acceptable, it must be resubmitted alongside a revised application. Comments on the overall prescribing information are reserved until other deficiencies are resolved. Supernus is required to fully address all issues within one year by resubmitting a complete response, or it risks withdrawal of the application. The company may also request a meeting with the FDA to discuss the necessary steps for approval. The drug product cannot be legally marketed until written approval is granted.