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# Foradil Not Withdrawn Due to Safety/Efficacy
- URL: https://www.fdaweb.com/foradil-not-withdrawn-due-to-safety-efficacy/
- Published: 2023-11-06T12:00:00.000Z
- Updated: 2026-09-14T14:15:19.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5155726

*Federal Register* notice: FDA has determined that Novartis’ Foradil (formoterol fumarate) inhalation powder (.012 mg) was not withdrawn due to safety or effectiveness concerns. The determination will allow the agency to approve ANDAs referencing the product if all other legal and regulatory requirements are met. Foradil is indicated for treating asthma in patients five years of age and older as an add-on to a long-term asthma control medication such as an inhaled corticosteroid. It is also used for preventing exercise-induced bronchospasm, and maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2023-11-06/pdf/2023-24506.pdf?ref=fdaweb.com).