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Entecavir

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AUG 18, 2026 · REGULATORY LABEL UPDATE

FDA supplemental approval: Baraclude (Labeling)

U.S. Food and Drug Administration

FDA supplemental approval for labeling changes to entecavir; does not report clinical trial outcomes or comparative efficacy data.

Regulatory UpdateEntecavir Bristol Myers Squibb

Reported

Approval date2026-08-18

Product formulations approvedEntecavir 0.5 mg tablet; Entecavir 1 mg tab…

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