Perrigo announced that the FDA has granted final approval on its Abbreviated New Drug Application (ANDA) for Azelastine HCl Nasal Spray 0.15%, the generic version of Meda’s Astepro. Astepro is indicated for seasonal and perennial allergic rhinitis in patients >12 years old.
Azelastine HCl, a phthalazinone derivative, exhibits histamine H1-receptor antagonist activity in isolated tissues, animal models, and humans. Azelastine HCl is administered as a racemic mixture with no difference in pharmacologic activity noted between the enantiomers in in vitro studies. The major metabolite, desmethylazelastine, also possesses H1-receptor antagonist activity.
For more information call (866) 634-9120 or visit Perrigo.com.