Lannett Receives FDA Approval For Sumatriptan Nasal Spray USP, 5mg And 20mg

Feb 22, 2016, 06:57 ET from Lannett Company, Inc.

PHILADELPHIA, Feb. 22, 2016 /PRNewswire/ -- 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."

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

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

This news release contains certain statements of a forward-looking nature relating to future events or future business performance. Any such statement, including, but not limited to, successfully commercializing Sumatriptan Nasal Spray USP, 5 mg/spray and 20 mg/spray, whether expressed or implied, is subject to market and other conditions, and subject to risks and uncertainties which can cause actual results to differ materially from those currently anticipated due to a number of factors which include, but are not limited to, the risk factors discussed in the Company's Form 10-K and other documents filed with the SEC from time to time, including the prospectus supplement related to the proposed offering to be filed with the SEC. These forward-looking statements represent the Company's judgment as of the date of this news release. The Company disclaims any intent or obligation to update these forward-looking statements.


Robert Jaffe

Robert Jaffe Co., LLC

(424) 288-4098

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SOURCE Lannett Company, Inc.