Akorn Receives FDA Approval for Azelastine Hydrochloride Nasal Spray, 0.15%

Akorn, Inc. (Nasdaq: AKRX), a leading specialty generic pharmaceutical company, today announced that it received a new Abbreviated New Drug Application (ANDA) approval from the U.S. Food and Drug Administration (FDA) for Azelastine Hydrochloride Nasal Spray, 0.15%. The product is manufactured at Akorn’s Amityville, New York manufacturing facility.

According to IQVIA, U.S. sales of Azelastine Hydrochloride Nasal Spray, 0.15% were approximately $18 million for the twelve months ended June 2019. Azelastine Hydrochloride Nasal Spray, 0.15% is indicated for the relief of the symptoms of seasonal allergic rhinitis in patients 6 years of age and older and perennial allergic rhinitis in patients 6 years of age and older. About AkornAkorn, Inc. is a specialty generic pharmaceutical company engaged in the development, manufacture and marketing of multisource and branded pharmaceuticals. Akorn has manufacturing facilities located in Decatur, Illinois; Somerset, New Jersey; Amityville, New York; Hettlingen, Switzerland and Paonta Sahib, India that manufacture ophthalmic, injectable and specialty sterile and non-sterile pharmaceuticals. Additional information is available on Akorn’s website at www.akorn.com. Investors/Media:(847) [e-mail]