Xspray Pharma has encountered another regulatory hurdle as the FDA declined approval of its new drug application for Dasynoc, a lower-dose, bioequivalent formulation of dasatinib for chronic myeloid leukemia (CML) and acute lymphoblastic leukemia (ALL). The FDA issued a complete response letter citing Good Manufacturing Practice (GMP) observations at Xspray’s contract manufacturing facility, though no direct concerns were raised about the specific production line used for Dasynoc.
Regulatory authorities have paused all new product approvals at the manufacturing site until corrective actions are verified. Xspray has stated that its contractor has already initiated remediation and a follow-up meeting with the FDA is planned for December to address the outstanding GMP issues. This marks the third FDA rejection for Dasynoc, reflecting continued challenges for the company in bringing its product to market.
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