Drug or technology

Buprenorphine Hydrochloride

3 developments in the corpus

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AUG 14, 2026 · REGULATORY LABEL UPDATE

FDA supplemental approval: Buprenorphine Hydrochloride (REMS)

U.S. Food and Drug Administration

FDA supplemental approval action establishing Risk Evaluation and Mitigation Strategy (REMS) requirements for buprenorphine hydrochloride sublingual tablets; does not report clinical trial outcomes.

Regulatory UpdateBarr Buprenorphine Hydrochloride

Reported

Approval status date2026-08-14

Product strengths approved2 mg base, 8 mg base

JUL 10, 2026 · REGULATORY LABEL UPDATE

FDA supplemental approval: Buprenorphine Hydrochloride (Manufacturing (CMC))

U.S. Food and Drug Administration

FDA supplemental approval of a manufacturing/CMC change for an existing buprenorphine hydrochloride product; does not report clinical trial data or comparative efficacy.

Regulatory UpdateBuprenorphine Hydrochloride Rubicon Research

Reported

Approval date2026-07-10

Product strengths approved2 mg, 4 mg, 8 mg, 12 mg base

Application numberANDA090279

JUN 18, 2026 · REGULATORY LABEL UPDATE

FDA supplemental approval: Belbuca (REMS)

U.S. Food and Drug Administration

This is an FDA supplemental approval action for a Risk Evaluation and Mitigation Strategy (REMS) modification to an existing buprenorphine product; it does not report clinical trial data or comparative efficacy.

Regulatory UpdateBdsi Buprenorphine Hydrochloride

Reported

Approval date2026-06-18

Product formulationBuccal film

Approved strengths (mg base)0.075, 0.3, 0.45, 0.75