Glenmark gets USFDA approval for Fluticasone Propionate Inhalation Aerosol

India, March 4 -- 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 product has been confirmed by the USFDA to be bioequivalent and therapeutically equivalent to the reference listed drug FloVent® HFA Inhalation Aerosol, 44 mcg, developed by GlaxoSmithKline Intellectual Property Ltd., England (NDA – 021433).

Glenmark has also been granted a Competitive Generic Therapy (CGT) designation 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 commercialization.

The p...