When was apotex's ruxolitinib approved?

Apotex’s generic version of ruxolitinib (the drug marketed as Ruxolitinib Tablets) received its first U.S. FDA approval on October 12, 2021.

- Indication at approval: treatment of myelofibrosis in adults.
- Background: The brand‑name formulation (Jakafi®) was originally approved by the FDA in 2014. Apotex’s generic was cleared as a “suspension” of the brand’s active ingredient, meeting the FDA’s “Abbreviated New Drug Application” (ANDA) requirements for generics.

If you’re interested in the Canadian approval, Apotex’s generic ruxolitinib was approved by Health Canada a few months earlier (late 2020/early 2021, depending on the exact product release), but the U.S. date is the most commonly cited milestone.