> ## 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.

# Fortamet Not Withdrawn Due to Safety/Efficacy: FDA
- URL: https://www.fdaweb.com/fortamet-not-withdrawn-due-to-safety-efficacy-fda/
- Published: 2019-07-29T12:00:00.000Z
- Updated: 2026-09-15T01:40:36.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5144637

*Federal Register* notice: FDA has determined that Andrx Labs’ Fortamet (metformin hydrochloride) extended-release tablets, 500 mg and 1 g, were not withdrawn from sale for safety or effectiveness reasons. The determination means that FDA can continue to approve ANDAs that refer to these products as long as they meet relevant legal and regulatory requirements. Fortamet is indicated as an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2019-07-29/pdf/2019-16008.pdf?ref=fdaweb.com).