Zydus Lifesciences

AUG 3, 2026 · REGULATORY APPROVAL

FDA approval: Indocyanine Green

U.S. Food and Drug Administration

This is an FDA approval action for a generic indocyanine green injectable product; it confirms regulatory authorization but does not report clinical trial data or comparative efficacy.

JUL 15, 2026 · REGULATORY LABEL UPDATE

FDA supplemental approval: Metformin Hydrochloride (Labeling)

U.S. Food and Drug Administration

This is an FDA supplemental approval action for metformin hydrochloride labeling; it documents a regulatory decision, not clinical evidence of efficacy or safety.

JUL 15, 2026 · REGULATORY LABEL UPDATE

FDA supplemental approval: Metformin Hydrochloride (Labeling)

U.S. Food and Drug Administration

This is an FDA supplemental approval action for metformin hydrochloride labeling; it documents a regulatory decision, not clinical trial efficacy or safety data.

MAR 31, 2026 · REGULATORY LABEL UPDATE

FDA supplemental approval: Methylene Blue (Manufacturing (CMC))

U.S. Food and Drug Administration

FDA supplemental approval for manufacturing changes to methylene blue intravenous solutions; confirms compliance with Chemistry, Manufacturing, and Controls standards but does not report clinical efficacy or safety data.

MAR 18, 2026 · REGULATORY LABEL UPDATE

FDA supplemental approval: Vigabatrin (REMS)

U.S. Food and Drug Administration

FDA supplemental approval of vigabatrin under a Risk Evaluation and Mitigation Strategy (REMS), a regulatory action governing drug safety monitoring and use conditions rather than efficacy evidence.