The FDA has approved Akorn’s ANDA for its azelastine hydrochloride nasal spray, 0.15%, for the treatment of allergic and perennial rhinitis in patients 6 years old and older, the company said. In May 2019, the FDA approved Akorn’s 0.1% azelastine hydrochloride nasal spray.
According to Akorn, the nasal spray is manufactured at the company’s facility in Amityville, New York, USA. The company acquired that facility and the azelastine hydrochloride nasal sprays when it acquired Hi-Tech Pharmacal in 2014.
Read the Akorn press release.
