Glenmark Specialty SA has received approval from the U.S. FDA for fluticasone propionate inhalation aerosol USP, 44 mcg per actuation. The FDA says the treatment is the first generic of Flovent HFA, manufactured by GSK, for maintenance of asthma.

Glenmark plans to begin distributing the treatment, which deepens its respiratory portfolio, in the U.S. in March 2026. Due to the approval, a Competitive Generic Therapy (CGT) designation, Glenmark will get 180 days of CGT exclusivity at commercialization.

Glenmark Reaction to Generic Approval

In a press release, Marc Kikuchi, Glenmark President and Business Head, North America, reacted to the launch. Kikuchi said Glenmark wants to improve access to “quality and affordable respiratory treatments for patients and healthcare providers.”

“Receiving approval … marks an important milestone in strengthening our respiratory portfolio in the U.S.,” Kikuchi said. “The CGT designation and first approved applicant status reflect the technical expertise and dedication of our teams.”

Sales data are available for GSK’s FloVent for a 12-month period ending with January 2026. Those numbers show achieved annual sales of approximately $520.1 million.

FDA Says Fluticasone Generic is Crucial

Iilun Murphy, MD, Director, Office of Generic Drugs, FDA Center for Drug Evaluation and Research, said a generic is critical. That is in the context of the nearly 25 million Americans affected by asthma. Almost one-fifth of these (4.6 million) are children.

An estimated 10 million asthma attacks occur each year in the U.S. Moreover, 3500 deaths—both children and adults—are annually attributed to asthma.

“The first generic fluticasone propionate inhalation aerosol represents an important step in expanding access to affordable asthma treatment,” Murphy said. “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.”