Lannett Announces Approval For Metaxalone Tablets USP, 800 Mg
Published: Nov 28, 2016
PHILADELPHIA, Nov. 28, 2016 /PRNewswire/ -- Lannett Company, Inc. (NYSE: LCI) today 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."
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.
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 Metaxalone Tablets USP, 800 mg, potential future litigation of the product, 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 Co., LLC
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SOURCE Lannett Company, Inc.