FDA approves Actavis’ generic Suboxone ANDA to treat opioid dependence
Published on February 26, 2013 at 12:52 AM
Actavis, Inc. (NYSE: ACT) today announced that it has received approval from the U.S. Food and Drug Administration (FDA) on its Abbreviated New Drug Application (ANDA) for Buprenorphine HCl and Naloxone HCl Dihydrate SL Tablets, 2 mg/0.5 mg and 8 mg/2 mg, the generic equivalent to Reckitt Benckiser Healthcare's Suboxone®.
Actavis intends to begin shipping the product immediately. Suboxone® is indicated for maintenance treatment of opioid dependence.
For the 12 months ending December 31, 2012, Suboxone® tablets had total U.S. sales of approximately $625 million, according to IMS Health data.