Lannett Company Inc announced that it received approval from the U.S. 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. Â
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.
“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. Â “This approval comes from our wholly owned subsidiary, Kremers Urban Pharmaceuticals, and will further diversify our product offering. Â 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. Â For more information, visit the company’s website at www.lannett.com
Robert Jaffe
Robert Jaffe Co., LLC
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