Glenmark Pharmaceuticals, a global pharmaceutical company focused on innovation and accessibility, announced FDA approval for Fluticasone Propionate Inhalation Aerosol USP, 44 mcg per actuation, on March 4th, 2026. According to a company press release, FDA granted the treatment a Competitive Generic Therapy (CGT) designation, meaning the agency considers it to be bioequivalent and therapeutically equivalent to GSK’s FloVent.

According to IQVIA sales data cited in the release, FloVent achieved annual sales of approximately $520.1 million for the 12-month period ending in January 2026. Due to its CGT designation, Fluticasone will receive 180 days of CGT exclusivity upon commercialization. The company expects to begin U.S. distribution later this month.

“Receiving approval for Fluticasone Propionate Inhalation Aerosol USP, 44 mcg per actuation marks an important milestone in strengthening our respiratory portfolio in the U.S. The CGT designation and first approved applicant status reflect the technical expertise and dedication of our teams in bringing complex inhalation therapies to market,” said Marc Kikuchi, President & Business Head, North America, Glenmark Pharmaceuticals, in the release. “We remain committed to improving access to quality and affordable respiratory treatments for patients and healthcare providers.”