Actavis announced that the FDA has approved its Abbreviated New Drug Application (ANDA) for Buprenorphine HCl and Naloxone HCl Dihydrate SL Tablets, the generic version of Reckitt Benckiser‘s Suboxone.
Suboxone is a combination of buprenorphine, an opioid (partial agonist-antagonist), and naloxone, an opioid antagonist. It is indicated for the maintenance treatment of opioid dependence.
Buprenorphine HCl and Naloxone HCl Dihydrate SL Tablets will be available in 2mg/0.5mg and 8mg/2mg strengths. Actavis intends to begin shipping the product immediately.
For more information call (800) 432-8534 or visit www.actavis.us