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# FDA Denies Apixaban ANDA Petition for Safety
- URL: https://www.fdaweb.com/fda-denies-apixaban-anda-petition-for-safety/
- Published: 2023-11-29T12:00:00.000Z
- Updated: 2026-09-14T14:17:19.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5155876

FDA has denied a 10/3/2017 petition submitted by Axinn, Veltrop & Harkrider requesting permission to submit an ANDA for apixaban tablets 10 mg, with a reference-listed drug of Bristol-Myers Squibb’s Eliquis in 2.5 mg and 5 mg doses. The denial [letter](https://downloads.regulations.gov/FDA-2017-P-6020-0006/attachment%5F1.pdf?ref=fdaweb.com) says the proposed change in strength raises questions of safety by potentially increasing the risk of medication error.

“The proposed new strength would, at a minimum, require significant labeling changes to support approval of the drug product,” the letter says. “Such labeling changes may, in addition, need to be supported by new studies to demonstrate the safety of the proposed new strength.”