Dr. Reddy’s has received final approval from the U.S. Food and Drug Administration (FDA) 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.
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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.
In a statement released by the FDA, Commissioner Scott Gottlieb, M.D., said, “The FDA is taking new steps to advance the development of improved treatments for opioid use disorder, and to make sure these medicines are accessible to the patients who need them. That includes promoting the development of better drugs, and also facilitating market entry of generic versions of approved drugs to help ensure broader access.”
“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,” said Alok Sonig, Chief Executive Officer, Developed Markets. “We are excited to be launching this important product that will help enable patients to prevail over this insidious disease.”
The Suboxone brand had U.S. sales of approximately $1.86 billion MAT for the most recent twelve months ending in April 2018 according to IMS Health.