Incyte reports 3 product complaints for Opzelura cream; suspends affected batches

INCYTE CORP

Three product complaints received for Opzelura (ruxolitinib) cream related to texture.
FDA notified; root cause analysis underway; early testing shows no safety/efficacy issues.
Texture issue due to small amount of API not fully dissolved, causing slight gritty texture.
Distribution of affected batches suspended; no commercial supply issues at this time.
60g tubes that passed release and 90-day QC remain available; manufacturing continues.

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