FDA approves Lannett's ANDA for Sumatriptan Nasal Spray USP

Lannett Company, Inc. (NYSE: LCI) today announced that it has received approval from the U.S. Food and Drug Administration (FDA) of its Abbreviated New Drug Application (ANDA) for Sumatriptan Nasal Spray USP, 5 mg/spray and 20 mg/spray, the therapeutic equivalent to the reference listed drug Imitrex^® Nasal Spray, of GlaxoSmithKline. According to IMS, total U.S. sales in 2015 of Sumatriptan Nasal Spray USP, 5 mg/spray and 20 mg/spray at Average Wholesale Price (AWP) were approximately $62 million.

"We believe our Sumatriptan Nasal Spray USP, 5 mg/spray and 20 mg/spray will be a first-to-market generic product," said Arthur Bedrosian, chief executive officer of Lannett. "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. We expect to commence marketing the product in the next several months."