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Pharma major Dr Reddy’s Laboratories Ltd has received final approval from the US Food and Drug Administration for Buprenorphine and Naloxone Sublingual Film. It is a therapeutic equivalent generic version of Suboxone (buprenorphine and naloxone) sublingual film.
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 programme, including prescription monitoring, counselling, and psychosocial support.
“With opioid addiction becoming increasingly prevalent in America, the full approval and launch of our generic equivalent of Suboxone could not have come at a more critical time to help patients,” Alok Sonig, Chief Executive Officer, Developed Markets, said in a release issued here on Friday. The approval is an important milestone for Hyderabad-based Dr Reddy’s.
The suboxone brand had US sales of approximately $1.86 billion for the most recent 12 months ended in April 2018, according to IMS Health.
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