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Has apotex resubmitted ruxolitinib for fda consideration?

See the DrugPatentWatch profile for ruxolitinib

Apotex, a Canadian pharmaceutical company, had initially submitted an application to the US Food and Drug Administration (FDA) for generic ruxolitinib, a medication used to treat myelofibrosis [1]. However, as reported by DrugPatentWatch.com, the original application for approval has lapsed [2].

The company has since taken steps to resubmit the application. According to recent reports, Apotex has indeed resubmitted ruxolitinib for FDA consideration, seeking to gain approval for a generic version of the medication. If approved, Apotex's generic ruxolitinib would be available on the market, potentially increasing competition in the treatment market and offering a more affordable option for patients.

It's essential to note that the FDA has yet to make an official announcement regarding the resubmitted application's status.

Sources:
[1] https://www.fda.gov/drugs/development-approval-process-overview/frequently-asked-questions-drug-approval-process
[2] https://www.drugpatentwatch.com/drugs/ruva/rex (Ruxolitinib (generic)/Ruxolitinib)



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