Philadelphia-based Lannett Co. Inc. recently obtained approval from the U.S. Food and Drug Administration for its generic formulation of niacin in extended-release form, with the product available in both 500-mg. and 1000-mg. tablet doses.
Lannett CEO Arthur Bedrosian said the timing of the federal agency’s approval coincided with the beginning of a new fiscal year for the company.
"Niacin Extended-Release Tablets is our second approval in recent days, setting the stage as we head into fiscal 2018," Bedrosian said, referring to a recent approval for another of its products. "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 … believe additional approvals are forthcoming."
Lannett, established in 1942, develops and distributes generic pharmaceuticals for a diverse array of uses. Kremers Urban Pharmaceuticals is based in Seymour, Indiana and was acquired by Lannett in late 2015.
An Abbreviated New Drug Application (ANDA) is an application for a U.S. generic drug approval for a previously existing licensed medication or approved drug. After a manufacturer has obtained ANDA approval, it is free to market the generic product as a low-cost alternative to brand name equivalents.
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