Breckenridge Announces Approval for Azelastine HCl Nasal Solution (Nasal Spray)

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Jul 29, 2015, 10:30 ET

BOCA RATON, Fla., July 29, 2015 /PRNewswire/ -- Breckenridge Pharmaceutical, Inc. announced today the immediate launch of Azelastine HCl Nasal Solution, 0.1%. The U.S. Food and Drug Administration granted final approval for this Abbreviated New Drug Application (ANDA), which is AB rated to Astelin®, a drug marketed by Meda Pharmaceuticals. Azelastine hydrochloride nasal solution (nasal spray) is a $69 million dollar generic market based on June 2015 IMS Health sales data. Azelastine HCl Nasal Solution 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 Breckenridge:
Breckenridge Pharmaceutical, Inc. is a privately-held pharmaceutical marketing, research and development company founded in 1983 that markets a broad range of generic prescription products in many therapeutic categories. The Breckenridge label is recognized by wholesalers, distributors, chains, and managed care accounts, as well as retail pharmacies nationwide. The company markets over 70 products in a variety of dosage forms including: tablets, capsules, soft gel capsules, liquids, suspensions, and powders. www.bpirx.com

*Astelin and MEDA Pharmaceuticals are registered trademarks of Meda Pharmaceuticals Inc.

SOURCE Breckenridge Pharmaceutical, Inc.