Glenmark Specialty SA has received final U.S. FDA approval for its Fluticasone Propionate Inhalation Aerosol USP, 44 mcg per actuation. The product has been designated as bioequivalent to the reference drug, FloVent® HFA Inhalation Aerosol. Crucially, Glenmark is the “first approved applicant” under the Competitive Generic Therapy (CGT) designation, granting the company 180 days of market exclusivity upon commercialization starting in March 2026.
U.S. FDA Grants Final Approval for Respiratory Product
Glenmark Specialty SA (Glenmark) announced on March 04, 2026, that it has secured final approval from the United States Food & Drug Administration (U.S. FDA) for its Fluticasone Propionate Inhalation Aerosol USP, 44 mcg per actuation.
The FDA has determined that Glenmark’s product is both bioequivalent and therapeutically equivalent to the reference listed drug (RLD), FloVent® HFA Inhalation Aerosol (44 mcg), manufactured by GlaxoSmithKline Intellectual Property Ltd. England (NDA – 021433).
Competitive Generic Therapy Exclusivity Secured
A significant aspect of this approval is the Competitive Generic Therapy (CGT) designation awarded to Glenmark for this specific inhalation aerosol. As the “first approved applicant” under section 505(j)(5)(B)(v)(III) of the FD&C Act, Glenmark is now eligible for 180 days of CGT exclusivity immediately following the start of commercialization.
This approval is expected to further strengthen Glenmark’s respiratory portfolio within the U.S. market, emphasizing its commitment to expanding access to high-quality inhalation therapies.
Market Context and Launch Plans
The approval milestone is strategically important, as the market for the reference product, FloVent® HFA Inhalation Aerosol (44 mcg), generated approximately $520.1 million in annual sales for the 12-month period ending January 2026, according to IQVIA™™ data.
Glenmark Pharmaceuticals Inc., USA, will handle the distribution of the product in the United States, commencing in March 2026.
Leadership Commentary
Marc Kikuchi, President & Business Head, North America, commented that receiving this approval marks an “important milestone”. He highlighted that the CGT designation and first-approved applicant status reflect the technical expertise required to bring complex inhalation therapies to market, underscoring the commitment to providing “quality and affordable respiratory treatments”.
Source: BSE
