Mumbai, March 4 -- 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 eligib...