Xspray Pharma shares new information on Dasynoc (dasatinib formulation),for chronic myeloid leukemia (CML) and acute lymphocytic leukemia (ALL)
Xspray Pharma AB has received a Complete Response Letter (CRL) from the FDA regarding the New Drug Application (NDA) for Dasynoc, a novel treatment for chronic myeloid leukemia (CML) and acute lymphocytic leukemia (ALL)
The updated NDA was sent to the FDA on January 31, 2024. In the CRL the FDA requests additional information pertaining to the labeling comprehension and the pre-approval inspection at the third party’s manufacturing site, which was conducted 10 to 19 of June, 2024. Importantly, the FDA does not request additional clinical studies, nor does it question any submitted stability or clinical data.
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