Amneal Approved for Generic Suboxone

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Buprenorphine (as HCl), naloxone (as HCl dihydrate); 2mg/0.5mg, 8mg/2mg sublingual tablets by Amneal
Buprenorphine (as HCl), naloxone (as HCl dihydrate); 2mg/0.5mg, 8mg/2mg sublingual tablets by Amneal

Amneal Pharmaceuticals announced that the FDA has approved Buprenorphine HCl and Naloxone HCl Dihydrate Sublingual 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. The product received FDA approval under an approved Risk Evaluation and Mitigation Strategy (REMS), known as the Buprenorphine-containing Transmucosal products for Opioid Dependence (BTOD) REMS program.

Buprenorphine HCl and Naloxone HCl Dihydrate Sublingual Tablets are available in 2mg/0.5mg and 8mg/2mg strengths in 30-count bottles. The tablets will be available when the BTOD REMS program becomes operational in early March.

For more information call (866) 525-7270 or visit www.amneal.com
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