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# Rx NIX Not Withdrawn Due to Safety/Efficacy
- URL: https://www.fdaweb.com/rx-nix-not-withdrawn-due-to-safety-efficacy/
- Published: 2022-09-21T12:00:00.000Z
- Updated: 2026-09-14T18:00:06.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5152783

*Federal Register* notice: FDA has determined that GlaxoSmithKline’s prescription-only NIX (permethrin) 1% topical creme rinse was not withdrawn from sale for reasons of safety or effectiveness. However, because NIX (permethrin) 1% topical creme rinse has been approved for nonprescription use, any generic product referencing prescription NIX would be misbranded under FDA regulations if marketed with the “Rx only” symbol. Additionally, FDA says it will not approve ANDAs referencing the prescription product. NIX is indicated for the treating patients with head lice. To view the notice, click [here](https://public-inspection.federalregister.gov/2022-20520.pdf?ref=fdaweb.com).