The FDA has approved an ANDA for Akorn’s generic azelastine hydrochloride nasal spray for the treatment of seasonal allergic rhinitis in patients 5 years old and older and for vasomotor rhinitis in patients 12 and older, the company said.
According to the FDA web site, ANDA #207610 was submitted by Hi-Tech Pharmacal, which was acquired by Akorn in 2014. There are currently nine approved ANDAs for generic versions of Mylan’s Astelin nasal spray listed on the FDA site, including azelastine hydrochloride nasal sprays from Amneal, Breckenridge, and Sun Pharma.
Read the Akorn press release.
