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Classified in: Health
Subject: FDA

Lannett Receives Approval For Niacin Extended-Release Tablets USP, 500 Mg And 1000 Mg

PHILADELPHIA, June 19, 2017 /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 Niacin Extended-Release Tablets USP, 500 mg and 1000 mg, the therapeutic equivalent to the reference listed drug, Niaspan® Extended-Release Tablets, 500 mg and 1000 mg, of AbbVie Inc.  For the 12 months ended April 2017, total U.S. sales of Niacin Extended-Release Tablets USP, 500 mg and 1000 mg, at Average Wholesale Price (AWP) were approximately $152 million, according to IMS.

Lannett Logo (PRNewsFoto/Lannett Company, Inc.)

"Niacin Extended-Release Tablets is our second approval in recent days, setting the stage as we head into fiscal 2018," said Arthur Bedrosian, chief executive officer of Lannett.  "This approval comes from our wholly owned subsidiary, Kremers Urban Pharmaceuticals, and will further diversify our product offering.  We anticipate launching our product shortly and continue to believe additional approvals are forthcoming."

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 Niacin Extended-Release Tablets USP, 500 mg and 1000 mg, and expectations regarding 180 days of generic drug marketing exclusivity, 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


SOURCE Lannett Company, Inc.

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News published on 19 june 2017 at 06:53 and distributed by: