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US FDA Revokes Orphan Drug Designation For Indivior’s Sublocade

Executive Summary

In first-of-its-kind decision, agency concludes it relied on unreasonable assumptions regarding total market size, and failed to consider information about other dosage formulations, in granting designation for buprenorphine under the cost recovery provision; however, the FDA reaffirms that scope of Sublocade’s three-year exclusivity will keep Braeburn’s Brixadi off the market for another year.

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