Lannett (LCI) Receives FDA Approval of ANDA for Generic Skelaxin Tabs

November 28, 2016 6:55 AM EST

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Lannett Company, Inc. (NYSE: LCI) announced that it received approval from the U.S. Food and Drug Administration (FDA) of its Abbreviated New Drug Application (ANDA) for Metaxalone Tablets USP, 800 mg, the therapeutic equivalent to the reference listed drug, Skelaxin® of King Pharmaceuticals, Inc. According to IMS, total U.S. sales for the 12 months ended September 2016 of Metaxalone Tablets USP, 800 mg, at Average Wholesale Price (AWP) were approximately $173 million.

"Metaxalone Tablets, indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomforts associated with acute, painful musculoskeletal conditions, is the tenth product approval we have received in calendar 2016," said Arthur Bedrosian, chief executive officer of Lannett. "With only three current competitors, this approval represents a meaningful market opportunity. We anticipate launching our Metaxalone product within this quarter."



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