FDA Must Address Lannett's Lies On Cocaine Drug, Suit Says

Law360 (November 13, 2020, 6:22 PM EST) -- A small drugmaker is accusing the U.S. Food and Drug Administration in Maryland federal court of disregarding false information in a Lannett Co. application for a cocaine-based numbing agent, the latest chapter in the company's efforts to protect its cocaine anesthetic that has been on the market for years.

The FDA illegally failed to take steps to withdraw its approval of Lannett's new drug application for Numbrino, a cocaine-based anesthetic, after Genus Lifesciences Inc. told the regulator that Lannett lied about where it was manufacturing the product, Pennsylvania-based Genus says in a lawsuit filed Thursday.

"Genus brought these material, untrue statements...

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