FDA approves Lannett’s ANDA for Buprenorphine and Naloxone Sublingual Tablets

Lannett Company Inc. announced that the U.S. Food and Drug Administration (FDA) recently approved its Abbreviated New Drug Application (ANDA) for Buprenorphine and Naloxone Sublingual Tablets for the dosing options of 2 mg/0.5 mg and 8 mg/2mg.

The newly approved tablets are the therapeutic equivalent of Suboxone Sublingual Tablets with the same doses.

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

The FDA approved the Buprenorphine and Naloxone Sublingual Tablets under an approved Risk Evaluation and Mitigation Strategy (REMS), also known as the Buprenorphine-containing Transmucosal products for Opioid Dependence (BTOD) REMS program. The new product will be distributed according to FDA and Drug Enforcement Administration regulations that will govern the handling of CIII controlled substances.