Company

Laurus

2 developments in the corpus

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AUG 11, 2026 · REGULATORY LABEL UPDATE

FDA supplemental approval: Metformin Hydrochloride (Labeling)

U.S. Food and Drug Administration

FDA supplemental approval of labeling changes for metformin hydrochloride; regulatory action does not report clinical trial outcomes or efficacy data.

Regulatory UpdateLaurus Metformin Hydrochloride

Reported

Approval date2026-08-11

Application numberANDA209882

Submission classLabeling

JUL 10, 2026 · REGULATORY APPROVAL

FDA approval: Rilpivirine

U.S. Food and Drug Administration

FDA approval of a generic rilpivirine tablet formulation; regulatory action confirming bioequivalence and manufacturing standards, not a clinical efficacy trial.

Regulatory UpdateLaurus Rilpivirine

Reported

Drug strength25 mg base

Approval date2026-07-10