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FDA has approved generic buprenorphine hydrochloride (HCl) and naloxone HCl dihydrate sublingual tablets (Amneal Pharmaceuticals), the first generic versions of Suboxone (Reckitt Benckiser Healthcare (UK)) sublingual tablets for maintenance treatment of opioid drug dependence.
The generic version is now available in 2 mg/0.5 mg and 8 mg/2 mg strengths, both in 30-count bottles. Annual U.S. sales of Suboxone in all dosage forms are $1.5 billion, according to December 2012 IMS Health market data.
“The approval of generic Subxone by FDA serves as another noteworthy accomplishment because this provides another effective therapeutic option for the treatment of opioid dependence that will be available to prescribers and consumers,” said Abimbola Farinde, PharmD, MS, clinical staff pharmacist at Clear Lake Regional Medical Center, in Webster, Texas.
“The generic form of this drug offers prescribers access to a cost-effective alternative that they can prescribe to their patients and many patients can afford when it comes to the treating their addiction,” Dr. Farinde added.
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, and will be distributed in accordance with FDA and U.S. Drug Enforcement Administration 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.