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# FDA Accepts Atox Bio NDA Filing for Reltecimod
- URL: https://www.fdaweb.com/fda-accepts-atox-bio-nda-filing-for-reltecimod/
- Published: 2020-12-10T12:00:00.000Z
- Updated: 2026-09-14T16:39:39.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5148279

FDA has accepted for filing an Atox Bio NDA for reltecimod to treat suspected organ dysfunction or failure in patients age 12 and older with necrotizing soft tissue infections, in conjunction with surgical debridement, antibiotic therapy, and supportive care. The agency assigned a PDUFA action date of 9/30/21, Atox [says](https://www.marketwatch.com/press-release/atox-bio-announces-fda-acceptance-to-file-the-nda-for-reltecimod-to-treat-suspected-organ-dysfunction-or-failure-in-patients-with-necrotizing-soft-tissue-infection-flesh-eating-disease-2020-12-10?tesla=y&ref=fdaweb.com). The NDA was submitted under the FDA accelerated approval program.