Dr. Reddy's Laboratories Ltd. has said that it has received final approval from the U.S. Food and Drug Administration (USFDA) and is launching Buprenorphine and Naloxone Sublingual Film, 2 mg/0.5 mg, 4 mg/1 mg, 8 mg/2 mg, and 12 mg/3 mg, a therapeutic equivalent generic version of Suboxone ® (buprenorphine and naloxone) sublingual film, in the United States market. The product is being launched with an approved Risk Evaluation and Mitigation Strategy (REMS) Program. Buprenorphine and naloxone are used to treat adults with opioid dependence/addiction.
Buprenorphine helps suppress withdrawal symptoms caused by discontinuation of opioid drugs, and naloxone reverses and blocks the effect of opioids. This combination of medications is used as part of a complete treatment program including prescription monitoring, counseling, and psychosocial support. Meanwhile, shares of the company were trading at Rs 2328 apiece up 2.63 per cent from the previous close at 09:30 hrs on BSE.
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