Glenmark Pharmaceuticals on Wednesday said its subsidiary, Glenmark Specialty SA, has received final approval from the United States Food and Drug Administration for its inhaler fluticasone propionate inhalation aerosol USP, 44 mcg per actuation.
The inhalation aerosol will be distributed in the US by Glenmark Pharmaceuticals Inc, US, starting March. The approval strengthens the company’s respiratory portfolio in the world’s largest pharmaceutical market, where it has been expanding its presence in complex generics and inhalation therapies.
The product has been approved as bioequivalent and therapeutically equivalent to the reference listed drug, Flovent HFA Inhalation Aerosol (44 mcg), of GlaxoSmithKline Intellectual Property Ltd.
Glenmark said it has been granted Competitive Generic Therapy (CGT) designation for the product and qualifies as the “first approved applicant” under the US Federal Food, Drug, and Cosmetic Act. With this status, the company will be eligible for 180 days of CGT exclusivity upon commercial launch.
According to IQVIA sales data for the 12-month period ending January, the Flovent HFA 44 mcg market recorded annual sales of about $520 million, including brand and therapeutic equivalents.
Marc Kikuchi, President and 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 US.” “The CGT designation and first approved applicant status reflect the technical expertise and dedication of our teams in bringing complex inhalation therapies to market.”
The inhalation aerosol will be distributed in the US by Glenmark Pharmaceuticals Inc, US, starting March. The approval strengthens the company’s respiratory portfolio in the world’s largest pharmaceutical market, where it has been expanding its presence in complex generics and inhalation therapies.
The product has been approved as bioequivalent and therapeutically equivalent to the reference listed drug, Flovent HFA Inhalation Aerosol (44 mcg), of GlaxoSmithKline Intellectual Property Ltd.
Glenmark said it has been granted Competitive Generic Therapy (CGT) designation for the product and qualifies as the “first approved applicant” under the US Federal Food, Drug, and Cosmetic Act. With this status, the company will be eligible for 180 days of CGT exclusivity upon commercial launch.
According to IQVIA sales data for the 12-month period ending January, the Flovent HFA 44 mcg market recorded annual sales of about $520 million, including brand and therapeutic equivalents.
Marc Kikuchi, President and 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 US.” “The CGT designation and first approved applicant status reflect the technical expertise and dedication of our teams in bringing complex inhalation therapies to market.”
