> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Exelixis Wants 505(b)(2) Cabometyx Restrictions
- URL: https://www.fdaweb.com/exelixis-wants-505-b-2-cabometyx-restrictions/
- Published: 2026-04-14T12:00:00.000Z
- Updated: 2026-09-14T13:37:19.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5160984

Exelixis, which holds an NDA for Cabometyx (cabozantinib (S)-malate), a kinase inhibitor approved for several oncology indications, is asking FDA to impose restrictions on Handa Pharmaceuticals and any other companies submitting a 505(b)(2) NDA that references Cabometyx oral tablets. An Exelixis [petition](https://downloads.regulations.gov/FDA-2026-P-4022-0001/attachment%5F1.pdf?ref=fdaweb.com) says Handa’s proposed cabozantinib product includes a different cabozantinib salt and differs in pharmacokinetics and manufacturing process compared to Cabometyx, “raising new questions of safety and efficacy that may put patients at increased risk and that cannot be resolved solely by relying on FDA’s approval of Cabometyx.”

The petition asks FDA to:

- refuse to approve the Handa 505(b)(2) cabozantinib lauryl sulfate product and any cabozantinib lauryl sulfate products with similar genotoxic impurities and bioequivalence deficiencies, because available evidence shows that the salt switch has resulted in significant changes that are likely to raise novel questions of safety and effectiveness; and
- require Handa and similarly submitted 505(b)(2) applicants to submit adequate data demonstrating safety and effectiveness.