The US Food and Drug Administration (FDA) has approved Actavis' 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 US sales of approximately $625 million, according to IMS Health data.
Actavis, Inc. is a global, integrated specialty pharmaceutical company focused on developing, manufacturing and distributing generic, brand and biosimilar products.