Lannett (LCI) Says Buprenorphine and Naloxone Sublingual Tablets NDA Approved by FDA

September 20, 2016 7:09 AM EDT

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Lannett Company, Inc. (NYSE: LCI) announced that it received approval from the U.S. Food and Drug Administration (FDA) of its Abbreviated New Drug Application (ANDA) for Buprenorphine and Naloxone Sublingual Tablets, 2 mg/0.5 mg and 8 mg/2 mg, the therapeutic equivalent to the reference listed drug, Suboxone Sublingual Tablets, 2 mg/0.5 mg and 8 mg/2 mg. According to IMS, total U.S. sales in 2015 of Buprenorphine and Naloxone Sublingual Tablets, 2 mg/0.5 mg and 8 mg/2 mg, at Average Wholesale Price (AWP) were approximately $270 million.

"Buprenorphine and Naloxone Sublingual Tablets, a Class III drug, is an important medication for the treatment of opioid addiction," said Arthur Bedrosian, chief executive officer of Lannett. "This product represents another approval received from our wholly owned subsidiary, Kremers Urban Pharmaceuticals."

The product received FDA approval under an approved Risk Evaluation and Mitigation Strategy (REMS), known as the Buprenorphine-containing Transmucosal products for Opioid Dependence (BTOD) REMS program, and will be distributed in accordance with FDA and U.S. Drug Enforcement Administration (DEA) regulations governing the handling of CIII controlled substances.



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