Akorn Receives FDA Approval for Azelastine Hydrochloride Nasal Spray, 0.1%

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, 0.1%.

According to IQVIA, U.S. sales of Azelastine Hydrochloride Nasal Spray, 0.1% were approximately $46 million for the twelve months ended March 2019. Azelastine Hydrochloride Nasal Spray, 0.1% is indicated for the treatment of the symptoms of seasonal allergic rhinitis in adults and pediatric patients 5 years and older, and for the treatment of the symptoms of vasomotor rhinitis in adults and adolescent patients 12 years 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.

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