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# FDA Approves Cipla Generic Proventil HFA
- URL: https://www.fdaweb.com/fda-approves-cipla-generic-proventil-hfa/
- Published: 2020-04-08T12:00:00.000Z
- Updated: 2026-09-14T16:10:25.000Z
- Author: David McFarland
- Tags: Drugs, FDA Policy/General, #legacy-id-D5146528

FDA has approved Cipla Limited’s generic form of Merck’s Proventil HFA (albuterol sulfate) metered-dose inhaler 90 mcg/inhalation for treating or preventing bronchospasm in patients age four years and older who have reversible obstructive airway disease and for preventing exercise-induced bronchospasm in the same age group. It is the first approval of a generic albuterol inhaler.

An agency [notice](https://www.fda.gov/news-events/press-announcements/fda-approves-first-generic-commonly-used-albuterol-inhaler-treat-and-prevent-bronchospasm?ref=fdaweb.com) says it issued a 3/2020 revised draft product-specific [guidance](https://www.accessdata.fda.gov/drugsatfda%5Fdocs/psg/PSG%5F020503.pdf?ref=fdaweb.com) for proposed generic albuterol sulfate metered-dose inhalers, including products referencing Proventil. Among other things, the guidance provided bioequivalence recommendations.