Amneal Pharmaceuticals LLC said it has received U.S. FDA approval for generic versions of Suboxone sublingual tablets for maintenance treatment of opioid drug dependence.
Generic buprenorphine hydrochloride (HCl) and naloxone HCl dihydrate sublingual tablets are now available in 2 mg/0.5 mg and 8 mg/2 mg strengths, both in 30-count bottles.
The Amneal medication is bioequivalent to Suboxone, a registered trademark of Reckitt Benckiser Healthcare (UK) Limited (RB.L). Annual U.S. sales of Suboxone in all dosage forms are $1.5 billion, according to December 2012 IMS Health market data.
Manufactured in Amneal's fully FDA-compliant Brookhaven, NY facility, buprenorphine HCl and naloxone HCl tablets will be available through wholesalers and distributors as well as directly to the trade, the company said. The product received FDA approval under an approved Risk Evaluation and Mitigation Strategy or REMS, known as the Buprenorphine-containing Transmucosal products for Opioid Dependence or BTOD REMS program, and will be distributed in accordance with FDA and U.S. Drug Enforcement Administration or DEA regulations governing the handling of CIII controlled substances. The generic tablets will be available to patients when the BTOD REMS program becomes operational in early March.
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