Patheon Pharmaceuticals Inc. – FDA CRL

The FDA issued a Complete Response Letter (CRL) to Phathom Pharmaceuticals, Inc. regarding its New Drug Application (NDA 215151) for Voquezna (vonoprazan) tablets, submitted March 11, 2022. The agency determined that the application cannot be approved in its current form due to several deficiencies. The primary concerns, under 21 CFR 314.125(b)(1), relate to the inadequacy of manufacturing methods, facilities, and controls for the drug substance and product, impacting identity, strength, quality, purity, stability, and bioavailability. Specifically, the FDA noted the presence of an undisclosed impurity, necessitating a root cause investigation and revised acceptance criteria. The company must also submit new long-term and accelerated stability data for multiple batches of both 10 mg and 20 mg tablets, demonstrating compliance with updated specifications. Further actions required include submitting updated prescribing information and carton/container labeling that conform to FDA regulations (21 CFR 201.56(a), (d), and 201.57) and in structured product labeling (SPL) format. A comprehensive safety update, as per 21 CFR 314.50(d)(5)(vi)(b), is also mandated. Phathom Pharmaceuticals is encouraged to meet with the FDA to discuss their plan to address these issues before resubmission, which must occur within one year.