The FDA recently published a new product specific draft guidance for inhaled dry powder loxapine for development of generic versions of Adasuve loxapine inhalation powder, which was approved by the agency in December 2012 for the treatement of agitation in patients with schizophrenia or bipolar I disorder. All patents covering Adasuve listed in the Orange Book are slated to expire by the end of May 2024.
The agency also issued revisions of existing product specific draft guidances for the following products: azelastine hydrochloride / fluticasone propionate nasal spray (Dymista); fluticasone furoate nasal spray (Flonase Sensimist); fluticasone propionate nasal spray (Flonase); formoterol fumarate inhalation powder (Foradil); formoterol fumarate / mometasone furoate MDI (Dulera); glycopyrrolate inhalation powder (Seebri); glycopyrrolate / indacaterol maleate inhalation powder (Utibron); indacaterol maleate inhalation powder (Arcapta Neohaler); and mometasone furoate (Nasonex). Of those products, Dymista and Dulera are currently marketed as prescription drugs in the US; Flonase Sensimist is marketed OTC; Nasonex has switched to OTC; and the rest have been discontinued.
