Mylan announced that the Food and Drug Administration (FDA) has granted final approval for its Abbreviated New Drug Application (ANDA) for Buprenorphine HCl 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 HCl Sublingual Tablets are available in 2mg and 8mg strengths. Mylan has launched this product.
For more information call (800) RX-MYLAN or visit Mylan.com.