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Can you specify the official fda approval date of apotex's ruxolitinib?

See the DrugPatentWatch profile for ruxolitinib

Apotex’s generic version of ruxolitinib (the same active ingredient that Novartis markets as Jakafi) received its final FDA approval on **19 July 2023**.

  • The approval came via the FDA’s Abbreviated New Drug Application (ANDA) process, and the approval letter was issued on that date.
  • The drug was subsequently listed in the FDA’s Orange Book under the generic name “ruxolitinib.”

(For reference, the original brand‑name approval for ruxolitinib by Novartis was in 2011, but Apotex’s generic entry was approved in July 2023.)



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