The FDA has granted Braeburn Pharmaceuticals’ (BBRX) Citizen Petition seeking a revocation of Orphan Drug status for Indivior PLC’s (OTCPK:INVVY) Sublocade (buprenorphine extended-release) injection, approved in the U.S. on November 30, 2017 for the treatment of moderate-to-severe opioid addiction.
The action clears the way for full U.S. approval of Braeburn’s Brixadi (buprenorphine) effective December 1, 2020, instead of five years later as afforded by Orphan Drug status (Sublocade has a three-year period of clinical exclusivity).
The FDA tentatively approved Brixadi in December 2018. It filed the Citizen Petition in April of this year.
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