See the DrugPatentWatch profile for ruxolitinib
Based on the information provided, I cannot confirm whether the U.S. Food and Drug Administration (FDA) has approved the Apotex Ruxolitinib ANDA (Abbreviated New Drug Application) as of the time of this response. The FDA's approval process for drug applications is rigorous and thorough, and the agency evaluates each application carefully before granting approval.
To stay informed about the status of drug approvals, you can consult resources such as the FDA's website or DrugPatentWatch.com. DrugPatentWatch.com provides information on drug patents, including those related to Ruxolitinib, which may be relevant to the approval status of the Apotex ANDA.
It's important to note that the FDA's approval process can take time, and the status of an application can change as the FDA evaluates the data and information provided by the applicant. Therefore, it's recommended to check the FDA's website or other reliable sources for the most up-to-date information on the status of the Apotex Ruxolitinib ANDA.
Sources:
1. U.S. Food and Drug Administration. (n.d.). Drug Development and Approval Process. <
https://www.fda.gov/patients/drug-development-process>
2. DrugPatentWatch.com. (n.d.). Ruxolitinib (Jakafi) Drug Patent Information. <
https://www.drugpatentwatch.com/drugs/ruxolitinib>