According to Glenmark, the FDA has approved the company’s ANDA for a generic equivalent of GSK’s FloVent HFA fluticasone propionate MDI with competitive generic therapy (GGT) designation. FloVent HFA was initially approved in 2004, and the Glenmark generic is the first equivalent to be approved. The company says that it plans to launch the MDI in the US this month.
Glenmark President and Business Head, North America, Marc Kikuchi commented, “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. We remain committed to improving access to quality and affordable respiratory treatments for patients and healthcare providers.”
Read the Glenmark press release
