> ## 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.

# Levitra Not Withdrawn Due to Safety/Efficacy
- URL: https://www.fdaweb.com/levitra-not-withdrawn-due-to-safety-efficacy/
- Published: 2023-05-04T12:00:00.000Z
- Updated: 2026-09-14T18:29:43.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5154367

*Federal Register* notice: FDA has determined that Bayer’s Levitra (vardenafil HCl) oral tablets (5mg, 10mg and 20mg) were not withdrawn from sale due to safety or effectiveness reasons. The determination allows FDA to continue to approve ANDAs that reference the products as long as they meet relevant legal and regulatory requirements. Levitra is a phosphodiesterase 5 inhibitor indicated for treating erectile dysfunction. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2023-05-03/pdf/2023-09365.pdf?ref=fdaweb.com).