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PHILADELPHIA — Lannett Co. has received approval from the Food and Drug Administration for sumatriptan nasal spray (5 mg/spray and 20 mg/spray), a treatment for migraine headaches.
Lannett said its product is a generic version of Imitrex nasal spray from GlaxoSmithKline.
“We believe our sumatriptan nasal spray (USP, 5 mg/spray and 20 mg/spray) will be a first-to-market generic product,” Lannett chief executive officer Arthur Bedrosian said in a statement. “Producing nasal delivery medications requires unique expertise and facilities that few possess. Our sumatriptan nasal spray product was developed by Summit Biosciences Inc. and will be manufactured at its state-of-the-art facility located on the University of Kentucky’s Coldstream Research Campus.”
Lannett plans to begin marketing its sumatriptan nasal spray product in the next several months, Bedrosian added.
U.S. sales of sumatriptan nasal spray (5 mg/spray and 20 mg/spray) at average wholesale price (AWP) totaled approximately $62 million in 2015, according to IMS Health data reported by Lannett.
