Glenmark Specialty SA receives U.S. FDA final approval for Fluticasone Propionate Inhalation Aerosol USP, 44 mcg per actuation, bioequivalent to FloVent® HFA, with CGT designation granting 180-day exclusivity. Launching March 2026 via Glenmark Pharmaceuticals Inc., USA in a $520.1M market
Written By: Nikita Chaudhari BPharm
Reviewed By: Pharmacally Editorial Team
Glenmark Specialty SA (Glenmark) has earned final U.S. FDA approval for its Fluticasone Propionate Inhalation Aerosol USP, 44 mcg per actuation, a bioequivalent and therapeutically equivalent alternative to GlaxoSmithKline’s reference listed drug (RLD), FloVent® HFA Inhalation Aerosol, 44 mcg (NDA 021433).
This approval includes a coveted Competitive Generic Therapy (CGT) designation, positioning Glenmark as the “first approved applicant” under section 505(j)(5)(B)(v)(III) of the FD&C Act. As a result, Glenmark qualifies for 180 days of CGT exclusivity upon commercialization, offering a significant market advantage in the competitive respiratory segment.
Distributed by Glenmark Pharmaceuticals Inc., USA, the product will launch in the U.S. starting March 2026. This move bolsters Glenmark’s growing respiratory portfolio and reinforces its focus on delivering affordable, high-quality inhalation therapies to patients.
Market data from IQVIATM underscores the opportunity: FloVent® HFA Inhalation Aerosol, 44 mcg generated approximately $520.1 million in annual sales for the 12 months ending January 2026.
Marc Kikuchi, President & Business Head, North America, commented, “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. We remain committed to improving access to quality and affordable respiratory treatments for patients and healthcare providers.”
U.S. FDA announced this as the first generic approval of Flovent HFA (fluticasone propionate) inhalation aerosol, 44 mcg, specifically for maintenance treatment of asthma as prophylactic therapy in patients aged 4 years and older. This inhaled corticosteroid reduces lung inflammation to prevent symptoms like wheezing and shortness of breath, expanding access to affordable options amid rising costs.
Asthma affects nearly 25 million Americans, including 4.6 million children, with 10 million attacks yearly and 3,500 deaths. Flovent’s regular use cuts asthma hospitalizations and ICU admissions; this generic promises lower costs and broader availability for this serious condition.
“Today’s approval represents an important step in expanding access to affordable asthma treatment,” said Iilun Murphy, M.D., Director of the Office of Generic Drugs. Acting CDER Director Tracy Beth Høeg, M.D., Ph.D., added pride in CDER’s efforts to expedite this first generic metered-dose inhaler.
The generic matches Flovent HFA’s prescribing information, including contraindications for status asthmaticus, acute episodes, or hypersensitivity; warnings cover oropharyngeal candidiasis and immunosuppression. Consult full PI for complete details on precautions and adverse effects.
Reference
FDA approves first generic of Flovent HFA for treatment of asthma, 03 March 2026, https://www.fda.gov/drugs/drug-safety-and-availability/fda-approves-first-generic-flovent-hfa-treatment-asthma
Glenmark Specialty SA Receives U.S. FDA Approval for Fluticasone Propionate Inhalation Aerosol USP, 44 mcg per actuation, with 180-Day Competitive Generic Therapy Exclusivity, 04 March 2026, https://glenmark.b-cdn.net/gpl_pdfs/media/Press%20Release%20-%20Glenmark%20Specialty%20SA%20receives%20U.S.%20FDA%20approval%20for%20Fluticasone%20Propionate%20Inhalation%20Aerosol%20USP%2044%20mcg%20per%20actuation_FINAL.pdf
About Writer
Nikita Santosh Chaudhari, B.Pharm
She is a pharmacy graduate with a keen interest in clinical research, pharmacovigilance, and medical writing, particularly inclined towards publication writing and scientific content development. In her words, she is enthusiastic about scientific documentation and publication writing, aiming to contribute to accurate, ethical, and evidence-based medical communication.