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Sublocade Approval History

  • FDA approved: Yes (First approved November 30th, 2017)
  • Brand name: Sublocade
  • Generic name: buprenorphine
  • Dosage form: Sustained-Release Injection
  • Previous name: RBP-6000
  • Company: Indivior PLC
  • Treatment for: Opiate Dependence

Sublocade (buprenorphine) is a once-monthly injectable partial opioid agonist formulation for the treatment of opioid use disorder (OUD).

Development History and FDA Approval Process for Sublocade

Nov 30, 2017Approval FDA Approves Sublocade (buprenorphine) Once-Monthly Injection for Opioid Use Disorder
Oct 31, 2017FDA Advisory Committees Recommend Approval of Indivior’s RBP-6000 for the Treatment of Opioid Use Disorder
May 30, 2017Indivior Submits New Drug Application to U.S. FDA for RBP-6000 Buprenorphine Monthly Depot

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