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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 [Yahoo! Finan...

IQVIA Holdings, Inc. (IQV) 
Last iqvia holdings, inc. earnings: 4/28 07:00 am Check Earnings Report
US:NYSE Investor Relations: ir.iqvia.com
Company Research Source: Yahoo! Finance
FDA) for Fluticasone Propionate Inhalation Aerosol USP, 44 mcg per actuation. Glenmark Logo Glenmark's Fluticasone Propionate Inhalation Aerosol USP, 44 mcg per actuation has been determined by the FDA to be bioequivalent and therapeutically equivalent to the reference listed drug (RLD), FloVent® HFA Inhalation Aerosol, 44 mcg of GlaxoSmithKline Intellectual Property Ltd. England (NDA – 021433). Glenmark has been granted a Competitive Generic Therapy (CGT) designation for Fluticasone Propionate Inhalation Aerosol USP, 44 mcg per actuation and is the "first approved applicant" as defined in section 505(j)(5)(B)(v)(III) of the FD&C Act. Therefore, with this approval, Glenmark is eligible for 180 days of CGT exclusivity upon commercialization. Glenmark's Fluticasone Propionate Inhalation Aerosol USP, 44 mcg per actuation will be distributed in the U.S. by Glenmark Pharmaceuticals Inc., USA starting in March 2026. The approval further strengthens Glenmark's respiratory portfolio i Show less Read more
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