FDA CRL - REDHILL BIOPHARMA LTD

RedHill Biopharma Ltd. received a Complete Response Letter (CRL) from the FDA for its New Drug Application (NDA 205-394) for Rizaport (rizatriptan) oral film. The FDA, operating under the 505(b)(2) regulatory pathway, determined the application could not be approved due to significant deficiencies. Main issues included inadequate characterization of impurities, incomplete drug product specifications for physical characteristics, overly broad disintegration criteria, and unconfirmed dissolution methods. The container closure system lacked detailed descriptions, and stability data submissions were insufficient, notably for photostability. A recent facility inspection also identified unresolved deficiencies. Crucially, RedHill failed to provide the required notice to the patent owners (including Catalent entities) for Patent No. 5,457,895, associated with the referenced listed drug NDA 20865. Labeling also required revisions for clarity and content. RedHill must address all identified deficiencies, including product quality, facility issues, and the patent notification, before resubmitting the application within one year or requesting a meeting with the FDA.