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FDA Approves First Generic of Flovent HFA for Treatment of Asthma
On March 3, 2026, the U.S. Food and Drug Administration approved the first generic of Flovent HFA (fluticasone propionate) inhalation aerosol, 44 micrograms per actuation, for the maintenance treatment of asthma as prophylactic therapy in patients aged 4 years and older.
Flovent HFA is an inhaled corticosteroid used as maintenance treatment for asthma. It works by reducing inflammation in the lungs, helping to prevent asthma symptoms such as wheezing and shortness of breath.
"The approval of the first generic fluticasone propionate inhalation aerosol represents an important step in expanding access to affordable asthma treatment," said Iilun Murphy, M.D., Director of the Office of Generic Drugs in the FDA's Center for Drug Evaluation and Research. "Generic medications provide patients with safe, effective, and more affordable treatment options. The FDA remains committed to facilitating the development and approval of generic drugs to increase patient access to essential medicines."
Asthma affects almost 25 million Americans, 4.6 million of whom are children. There are an estimated 10 million asthma attacks per year, and 3,500 children and adults die each year from asthma. By making available a generic fluticasone propionate inhalation aerosol product, FDA has provided clinicians and the American public another available and valuable treatment option.
“Between 5 and 10% of Americans and just over 6% of children have an asthma diagnosis. Flovent is a highly effective preventive medication, which, when used regularly, has been linked to a reduction in asthma-related hospitalizations and admissions to intensive care. With the approval of the first generic metered dose inhaler form of the medication we anticipate increased availability and reduced costs of treating this prevalent and at times very serious condition” says Acting Director or CDER, Tracy Beth Hoeg, MD, PhD. “I am proud of the work CDER has done to bring this generic to market.”
The prescribing information for the generic fluticasone propionate inhalation aerosol includes the same contraindications, warnings, and precautions as Flovent HFA. Fluticasone should not be used as a primary treatment in status asthmaticus or in other acute episodes of asthma requiring intensive measures or in people with hypersensitivity to any of the product components. Fluticasone carries warnings such as oropharyngeal candidiasis and immunosuppression. The prescribing information should be consulted for a full description of warnings and precautions and adverse effects associated with the drug.
The FDA granted approval of fluticasone propionate inhalation aerosol to Glenmark Specialty SA. Please contact the manufacturer for information about the medicine’s availability.
Flovent HFA is a registered trademark of GlaxoSmithKline.
For more information about generic drugs, visit https://www.fda.gov/drugs/buying-using-medicine-safely/generic-drugs.
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