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Sublocade FDA Approval History

FDA Approved: Yes (First approved November 30, 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 timeline for Sublocade

Oct 28, 2022Last patient enrolled in study evaluating the efficacy of MODIA in combination with sublingual buprenorphine/ naloxone for the treatment of OUD
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

Further information

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