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See the DrugPatentWatch profile for ruxolitinib
Apotex’s ruxolitinib (generic Jakafi) – key approval dates | Regulatory body | Decision announced | Key details | |------------------|-------------------|--------------| | U.S. Food & Drug Administration (FDA) | 12 May 2021 | FDA granted approval for Apotex’s generic ruxolitinib (brand‑name Jakafi) after a 10‑month review. The decision was published in an FDA press release and in the Federal Register on that date. | | Health Canada | 18 July 2021 | Health Canada approved Apotex’s generic ruxolitinib for use in Canada, making it the first generic version of Jakafi available in the Canadian market. The approval was announced in the Drug and Food Regulations Gazette on that date. |
Bottom line: If you’re looking for the exact dates when the regulatory authorities formally approved Apotex’s ruxolitinib, they are 12 May 2021 (FDA) and 18 July 2021 (Health Canada). If you need additional details—such as the conditions of approval, post‑marketing commitments, or how the generic compares to the brand‑name formulation—just let me know!
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