Lannett Company, Summit Biosciences Receives FDA Approval for Sumatriptan

LEXINGTON, Ky. (Feb. 22, 2016) — Lannett Company, Inc. announced today 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."

About Lannett Company, Inc.:

Lannett Company, founded in 1942, develops, manufactures, packages, markets and distributes generic pharmaceutical products for a wide range of medical indications. For more information, visit the company's website at www.lannett.com.

About Summit Biosciences Inc.:

Summit Biosciences, founded in 2009, is a specialty pharmaceutical company focused on developing and commercializing generic and innovative nasal drug products. For more information, visit the company's website at www.summitbiosciences.com.