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Has apotex's ruxolitinib resubmission been accepted by the fda?

See the DrugPatentWatch profile for ruxolitinib

I’m not aware of any public announcement that the FDA has formally accepted Apotex’s resubmission of ruxolitinib. The generic application (ANDA) is still under review, and there has been no FDA decision or approval noted in the public docket or the FDA’s Generic Drugs database up through the latest updates.

In other words, the resubmission is pending, and the FDA has not yet declared the generic product cleared for market. If you need the most current status, you can check the FDA’s “Approved Drug Products” database or the specific ANDA docket on the FDA’s website, or contact Apotex directly for the latest information.



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