Xspray's Dasynoc blocked for a fourth time as FDA points to contract manufacturer
Swedish specialty pharma company Xspray Pharma (Nasdaq Stockholm: XSPRAY) has been turned away by the US Food and Drug Administration (FDA) for a fourth time, receiving a Complete Response Letter (CRL) for leukemia candidate Dasynoc on August 19, less than a week before a scheduled decision date of August 25.
The letter concerns outstanding good manufacturing practice (GMP) observations at NerPharMa, the Italian third-party manufacturer producing the drug, together with a request for further data from consecutive batches made at commercial scale following corrective actions already implemented. The agency raised no questions over clinical data, bioequivalence or stability.
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