Actavis announced that it has received final approval from the Food and Drug Administration (FDA) on its Abbreviated New Drug Application (ANDA) for Buprenorphine Sublingual Tablets, the generic version of Reckitt Benckiser’s Subutex.
Subutex is indicated for the treatment of opioid dependence. Buprenorphine is a partial agonist at the mu-opioid receptor and an antagonist at the kappa-opioid receptor.
Buprenorphine Sublingual Tablets will be available in 2mg and 8mg strengths. Actavis plans to begin shipping the product shortly.
For more information call (800) 432-8534 or visit Actavis.com.