Company

Breckenridge

2 developments in the corpus

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MAY 20, 2026 · REGULATORY LABEL UPDATE

FDA supplemental approval: Eplerenone (Labeling)

U.S. Food and Drug Administration

FDA supplemental approval for labeling changes to generic eplerenone; describes a regulatory action, not clinical evidence of efficacy or safety.

Regulatory UpdateEplerenone Breckenridge

Reported

Approval status date2026-05-20

Dosage strengths approved25 mg, 50 mg

APR 27, 2026 · REGULATORY LABEL UPDATE

FDA supplemental approval: Pomalidomide (REMS)

U.S. Food and Drug Administration

FDA supplemental approval of a Risk Evaluation and Mitigation Strategy (REMS) for pomalidomide; this is a regulatory action, not a clinical evidence assessment.

Regulatory UpdateBreckenridge Pomalidomide

Reported

Approval date2026-04-27

Submission classREMS

Approved dose strengths1 mg, 2 mg, 3 mg, 4 mg