Glenmark gets US FDA nod for new inhaler
Glenmark's subsidiary, Glenmark Specialty SA, has received final approval from the US FDA for its new inhaler, fluticasone propionate (44 mcg), which Glenmark will begin distributing in the US starting this March.
This move gives Glenmark a bigger slice of the US respiratory market and marks a big step for their presence in the States.
Glenmark gets a head start in the market
Glenmark's inhaler is officially as effective as GlaxoSmithKline's popular Flovent HFA, opening up access to a $520 million annual market.
Marc Kikuchi, President and Business Head, North America, said the approval "marks an important milestone in strengthening our respiratory portfolio in the US."
Thanks to a special FDA designation, Glenmark also gets 180 days where they're the only new generic on the block—helping them stand out in complex generics.