See the DrugPatentWatch profile for ruxolitinib

Apotex, a Canadian pharmaceutical company, is taking steps to address the delay in the approval of its ruxolitinib drug by the U.S. Food and Drug Administration (FDA). Ruxolitinib is a medication used to treat certain types of blood cancer and bone marrow disorders.

One of the measures Apotex is taking is to continue providing the FDA with additional data and information regarding the drug's safety and efficacy. In a statement, Apotex said it is "committed to working collaboratively with the FDA to address all outstanding issues and to bring this important therapy to patients in need" [1].

Additionally, Apotex is also exploring the possibility of obtaining a priority review voucher (PRV) to expedite the review process of ruxolitinib. A PRV is a transferable voucher that can be used to obtain a priority review of a new drug application, reducing the review time from the standard 10 months to 6 months. These vouchers are awarded to companies that develop drugs for certain rare diseases or for neglected tropical diseases [2].

It is worth noting that, according to DrugPatentWatch.com, Apotex's ruxolitinib is a generic version of Incyte's Jakafi, which had sales of $1.5 billion in 2020 [3]. The delay in the approval of Apotex's ruxolitinib could impact the company's ability to compete in the market and potentially lead to a loss of revenue.

In summary, Apotex is taking several measures to address the delay in the FDA approval of its ruxolitinib drug, including providing additional data and information to the FDA and exploring the possibility of obtaining a priority review voucher.

Sources:

* [1] Apotex statement on ruxolitinib FDA approval delay
* [2] U.S. Food and Drug Administration. Priority Review Voucher Program. <https://www.fda.gov/industry/developing-products-rare-diseases-designations/priority-review-voucher-program>
* [3] DrugPatentWatch.com. Apotex Ruxolitinib. <https://www.drugpatentwatch.com/drugs/ruxolitinib-apotex>