Glenmark Pharma secures USFDA nod for Fluticasone Propionate Inhalation Aerosol

Glenmark Pharmaceuticals announced that its subsidiary, Glenmark Specialty SA, has received final approval from the U.S. Food and Drug Administration (USFDA) for Fluticasone Propionate Inhalation Aerosol USP, 44 mcg per actuation.

The company said the product has been determined by the USFDA to be bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Flovent HFA Inhalation Aerosol, 44 mcg, of GlaxoSmithKline (NDA 021433).

Fluticasone propionate is indicated as an inhaler for the treatment and management of asthma by prophylaxis as well as inflammatory and pruritic dermatoses. Fluticasone propionate nasal spray is indicated for managing allergic and nonallergic rhinitis

Glenmark has also been granted a Competitive Generic Therapy (CGT) designation for the product and has been recognised as the first approved applicant under section 505(j)(5)(B)(v)(III) of the FD&C Act. With this approval, the company will be eligible for 180 days of CGT exclusivity upon commercial launch.

The inhalation aerosol will be distributed in the United States by Glenmark Pharmaceuticals Inc., USA starting March 2026. The approval further strengthens Glenmarks respiratory portfolio in the US and underscores its commitment to expanding access to complex inhalation therapies.

According to IQVIA sales data for the 12-month period ended January 2026, the Flovent HFA Inhalation Aerosol, 44 mcg market recorded annual sales of approximately $520.1 million.

Marc Kikuchi, President & Business Head, North America said, 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.

Glenmark Pharmaceuticals is engaged in the business of development, manufacturing, and marketing of pharmaceutical products, both formulations and active pharmaceutical ingredients, to regulated and semi-regulated markets.

Glenmark Pharmaceuticals, the company, reported a 15.9% jump in consolidated net profit to Rs 403.21 crore on a 17.8% increase in revenue from operations to Rs 3,888 crore in Q3 FY26 over Q3 FY25.

The counter dropped 4.07% to Rs 2,037 on the BSE.

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