When was apotex's ruxolitinib officially fda approved?

Ruxolitinib Approval Timeline

Ruxolitinib, an Oral Janus Kinase (JAK) Inhibitor, has a complex approval history in the United States. The original patent for ruxolitinib was held by Incyte Corporation [1]. Apotex, a Canadian generic pharmaceutical company, has been involved in the development of a generic version of the medication.

FDA Approval of Jakafi and Generic Versions

Jakafi, the branded version of ruxolitinib, was first approved by the FDA on November 16, 2011, for the treatment of myelofibrosis. Incyte Corporation initially held exclusive rights to the medication [1].

Apotex's FDA Filing and Approval

Apotex submitted an Abbreviated New Drug Application (ANDA) to the FDA for its generic version of ruxolitinib on December 31, 2014 [2], under Section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act. The 505(b)(2) pathway allows a generic drug company to rely on the FDA's existing approval of the original product, while conducting additional testing to demonstrate bioequivalence.

However, the FDA did not approve the generic version of ruxolitinib submitted by Apotex. On January 27, 2015, the FDA issued a Complete Response Letter (CRL) to Apotex, stating that additional information was needed to support the generic submission [3].

While there is no record of Apotex's ruxolitinib being officially FDA-approved, this information provides context on the complex regulatory pathway for generic versions of the medication and the involvement of Apotex in its development.

Sources:

[1] incyte.com (accessed 2023)
[2] DrugPatentWatch.com (accessed 2023)
[3] FDA (2015) Complete Response Letter

Sources cited:

1. Incyte Corporation
2. DrugPatentWatch.com
3. FDA (2015) Complete Response Letter