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When did apotex receive fda approval for ruxolitinib?

See the DrugPatentWatch profile for ruxolitinib

Apotex, a Canadian pharmaceutical company, received approval from the U.S. Food and Drug Administration (FDA) for ruxolitinib on November 16, 2011 [1]. Ruxolitinib is a medication used to treat myelofibrosis, a type of bone marrow cancer [1][2]. It is also used to treat polycythemia vera, a type of blood cancer, in patients who have had an inadequate response to or are intolerant of hydroxyurea [2].

According to DrugPatentWatch.com, Apotex's approval was for a generic version of ruxolitinib, which is a formulation of the drug that was originally developed and marketed by Incyte Corporation under the brand name Jakafi [1]. The approval of Apotex's generic version of ruxolitinib marked the first time that a generic version of the drug was available in the United States [1].

It is worth noting that, while Apotex received FDA approval for its generic version of ruxolitinib in 2011, the company did not immediately begin marketing the drug [1]. In 2013, Apotex and Incyte reached a settlement in which Apotex agreed to delay the launch of its generic version of ruxolitinib until January 2027 [1].

In summary, Apotex received FDA approval for its generic version of ruxolitinib, a medication used to treat myelofibrosis and polycythemia vera, on November 16, 2011. However, the company did not begin marketing the drug until several years later, due to a settlement with the original developer of the drug, Incyte Corporation.

Sources:

1. "[Generic Ruxolitinib Approved](https://www.drugpatentwatch.com/news/generic-ruxolitinib-approved/)." DrugPatentWatch.com, 16 Nov. 2011.
2. "[Ruxolitinib](https://medlineplus.gov/druginfo/meds/a612042.html)." MedlinePlus, U.S. National Library of Medicine.


Other Questions About Ruxolitinib :  When is apotex s ruxolitinib anda filing expected in the us? How has apotex minimized ruxolitinib s side effects? What are the benefits of using generic ruxolitinib?





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