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# Require In Vivo BE Test for Tafinlar ANDA: Petition
- URL: https://www.fdaweb.com/require-in-vivo-be-test-for-tafinlar-anda-petition/
- Published: 2026-06-10T12:00:00.000Z
- Updated: 2026-09-14T13:40:55.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5161287

A Windels Marx 5/29 petition asks FDA to ensure that any ANDA for dabrafenib mesylate capsules at the 150 mg (EQ Base) strength is supported by appropriate *in vivo* data and is therapeutically equivalent to Novartis’ cancer drug Tafinlar (dabrafenib). The [petition](https://www.amazon.com/s?k=shark+vacuum+brush+attachment&adgrpid=183288064221&hvadid=779584182435&hvdev=c&hvexpln=0&hvlocphy=9194943&hvnetw=g&hvocijid=14566699713929499106--&hvqmt=e&hvrand=14566699713929499106&hvtargid=kwd-302097341465&hydadcr=16258%5F13398507%5F2305777&mcid=851092c1fb3a3effade79bfba43122c6&tag=googhydr-20&ref=pd%5Fsl%5F257l38kbfq%5Fe) specifically asks that FDA refrain from approving any ANDA submitted pursuant to an approved suitability petition under section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act for dabrafenib mesylate capsules, 150 mg (EQ Base), unless and until the applicant has conducted and submitted to FDA an adequate and well-controlled *in vivo* bioequivalence study performed at a steady state in patients using the applicant’s proposed commercial 150 mg (EQ Base) dosage form, consistent with the design recommended in the FDA product-specific guidance (PSG) for dabrafenib mesylate oral capsules and applicable bioequivalence regulations.

The law firm says it does not seek any changes in the existing PSG or in the current FDA bioequivalence policy. Rather, it says, it seeks only the consistent and uniform application of the PSG, the underlying bioequivalence regulation, and the suitability petition framework to all applicants seeking to introduce a novel 150 mg (EQ Base) dabrafenib mesylate strength through the section 505(j)(2)(C) pathway.

Windels Marx says the relief sought is narrowly tailored and the firm does not seek and does not support any action that would delay approval of any ANDA referencing Tafinlar at the existing 50 mg or 75 mg strengths. It says it also does not seek any modification in the existing PSG, the suitability petition framework, or FDA’s general policies on the use of modeling and simulation.