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MARCH 6, 2025

FDA Approves Label Changes for Buprenorphine ER Injection

The FDA has approved label changes for buprenorphine extended-release (ER) injection (Sublocade, Indivior), including a rapid initiation protocol and alternative injection sites.

Healthcare providers can initiate treatment with buprenorphine ER after a single dose of transmucosal buprenorphine and a one-hour observation period to confirm tolerability. Buprenorphine ER also can be administered subcutaneously in the abdomen, thigh, buttock or back of the upper arm.

The FDA label changes can provide