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# FDA Denies Petition on Jakafi Safety Labeling
- URL: https://www.fdaweb.com/fda-denies-petition-on-jakafi-safety-labeling/
- Published: 2023-01-27T12:00:00.000Z
- Updated: 2026-09-14T18:13:34.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5153645

FDA has denied a 3/2021 petition filed by Loeb & Loeb on behalf of an unnamed client that asked the agency to take specific actions concerning the adequacy of safety labeling for Incyte’s JAK inhibitor drug Jakafi (ruxolitinib) tablets.

The [petition](https://downloads.regulations.gov/FDA-2021-P-0311-0001/attachment%5F1.pdf?ref=fdaweb.com) asked FDA to open a public docket to accept comments and views on the necessity of including uniform and consistent boxed warnings in the labeling of JAK (Janus Kinases) inhibitor drug products, and particularly in Jakafi tablets. In its [denial letter](https://downloads.regulations.gov/FDA-2021-P-0311-0004/attachment%5F1.pdf?ref=fdaweb.com), the agency said it receives scientific information from the public through multilple channels, and at this time it does not believe it is necessary to open an additional public docket.

In addition, the petition asked FDA whether Jakafi’s labeling should include the same boxed warnings as those required for the other products in the JAK inhibitor class. The denial letter said: “Considering the life-threatening nature of the diseases for which Jakafi is indicated, as well as the limited FDA-approved treatment options for these patients, we concluded that Jakafi’s different benefit-risk assessment warranted different labeling… We do not believe that the Jakafi labeling should include a warning of a detrimental effect on overall survival similar to that of the labeling for Xeljanz, Olumiant, and Rinvoq.”