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# Petition Seeks FDA Leukeran Actions
- URL: https://www.fdaweb.com/petition-seeks-fda-leukeran-actions/
- Published: 2025-02-13T12:00:00.000Z
- Updated: 2026-09-14T14:53:10.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5158656

A Buchanan Ingersoll & Rooney 2/6 petition asks FDA to take two specific actions regarding Leukeran (chlorambucil) 2 mg tablets, indicated to treat some leukemias and lymphomas. The petition specifically asks that FDA:

- maintain and strictly apply the requirements of the current product-specific guidance for chlorambucil, which represents scientifically appropriate standards for this class of drugs (oral chemotherapeutic dosage forms), to all pending, newly submitted, and future ANDAs for chlorambucil tablets; and
- pursuant to FDA’s biopharmaceutics classification system, refrain from granting a waiver of the requirement to perform *in vivo* bioequivalence testing for any generic formulation of chlorambucil.