Hetero Labs LTD V

JUL 14, 2026 · REGULATORY APPROVAL

FDA approval: Afatinib

U.S. Food and Drug Administration

FDA approval of a generic afatinib formulation; regulatory action without new clinical trial data or comparative efficacy claims.

JUL 1, 2026 · REGULATORY LABEL UPDATE

FDA supplemental approval: Capecitabine (Labeling)

U.S. Food and Drug Administration

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

JUN 10, 2026 · REGULATORY LABEL UPDATE

FDA supplemental approval: Valacyclovir (Labeling)

U.S. Food and Drug Administration

FDA supplemental approval of labeling changes for valacyclovir tablets; does not report clinical trial outcomes or comparative efficacy data.

MAY 27, 2026 · REGULATORY APPROVAL

FDA approval: Losartan Potassium AND Hydrochlorothiazide

U.S. Food and Drug Administration

FDA approval of a generic fixed-dose combination of losartan potassium and hydrochlorothiazide; this is a regulatory action, not a clinical trial, and does not contain efficacy or safety data.

APR 27, 2026 · REGULATORY LABEL UPDATE

FDA supplemental approval: Lenalidomide (REMS)

U.S. Food and Drug Administration

FDA supplemental approval of a REMS (Risk Evaluation and Mitigation Strategy) for lenalidomide generic formulations; does not report clinical trial data or efficacy evidence.

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 generic formulations; this is a regulatory action, not clinical evidence of efficacy or safety.