FDA approves first generic of Flovent for asthma

The FDA has approved the first generic of Flovent HFA (fluticasone propionate) inhalation aerosol to treat and control asthma in patients aged 4 years and older. It will be available sometime this month, but there is no information available yet on pricing.

Asthma affects almost 25 million Americans, 4.6 million of whom are children, according to the CDC. “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,” Acting Director of the agency’s CDER division, Tracy Beth Høeg, M.D., Ph.D., said in a news release.

Developed by Glenmark Specialty, the generic fluticasone propionate inhalation aerosol includes the same contraindications, warnings, and precautions as Flovent HFA. Fluticasone carries warnings such as oropharyngeal candidiasis (a fungal infection of the mouth) and immunosuppression.

As the first FDA-approved generic for Flovent HFA, fluticasone propionate will receive 180 days of market exclusivity through the agency’s competitive generic therapy program.

GlaxoSmithKline’s Flovent HFA was 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.

GSK had discontinued manufacturing of the branded Flovent HFA and Flovent Diskus in December 2023 to instead focus on the authorized generics of these products. GSK has been manufacturing an authorized generic of fluticasone since 2002, which is distributed by Prasco. GSK reports 2025 sales of fluticasone/Flovent as £421 million ($561 million), but this is likely from the authorized generic sales.

Glenmark’s generic is not an authorized generic. It is a product developed under the FDA’s generic drug program. The FDA requires evidence that the generic has the same active ingredient, is pharmaceutically equivalent and is processed by the body in the same way.

A study published in April 2025 in JAMA found that GSK’s discontinuation of the branded Flovent caused some disruption for patients, especially children. Researchers assessed data on inhaled steroid prescriptions for children and teens from IQVIA’s Longitudinal Prescription Database, which includes 92% of prescriptions from U.S. pharmacies. They found that some patients stopped using inhaled steroid therapy for their asthma, and this was more common among children and among Medicaid patients.

Separately, a different analysis published in JAMA Health Forum in November 2024 suggested that the discontinuation of the branded Flovent was a way to preserve sales for the company. In January 2024, a Medicaid rebate cap was removed. This cap limited what states could receive through rebate programs when prices exceeded the average manufacturer price. The elimination of the cap meant states could be eligible for higher rebates. This analysis suggested GSK could have lost $367.6 million per year after the rebate cap removal.

But researchers pointed out in both analyses, GSK’s authorized generic had not yet received preferred status on Medicaid and commercial plan formularies, leading to unintended consequences.