Xspray Pharma handed CRL from US regulators seeking more information about leukemia treatment

Xspray Phar­ma has been giv­en a com­plete re­sponse let­ter from the FDA over the NDA for its leukemia treat­ment Dasyn­oc, which it had ex­pect­ed to launch in the sec­ond half of this year.

The Swedish biotech said Tues­day that the FDA wants the biotech to give more in­for­ma­tion to doc­tors and users about the dos­ing of Dasyn­oc. It is al­so seek­ing in­for­ma­tion about “a third-par­ty man­u­fac­tur­ing fa­cil­i­ty,” where an in­spec­tion is on­go­ing.

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