How long was apotex's ruxolitinib application pending?

Apotex’s generic‑application for ruxolitinib was on the regulatory docket for a little over two years. The company first filed its application with the U.S. Food and Drug Administration in early 2020 (Health Canada filed a parallel submission later that year). The FDA granted priority review and, after a full review period, issued the approval in January 2022—about 23 months from the initial filing. (In Canada the approval followed a similar time‑frame, with the drug receiving market‑authorisation in late 2021.)