Lannett announced 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. 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," Arthur Bedrosian, chief executive officer of Lannett said. "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."