Novartis: Sandoz, Pear Therapeutics get FDA clearance for reSET-O

Sandoz, a division of Novartis, and Pear Therapeutics announced that the U.S. Food and Drug Administration has granted clearance for reSET-O as an adjunct to outpatient treatment that includes transmucosal buprenorphine and contingency management, for patients 18 years or older who are currently under the supervision of a clinician in outpatient treatment for Opioid Use Disorder. Under the terms of a commercial deal announced in April 2018, Sandoz will lead marketing and commercialization of reSET-O and reSET, Pear’s PDT for the treatment of Substance Use Disorder. Sandoz launched reSET in November 2018 and plans to launch reSET-O in the coming days in the U.S.
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