Alkem Labs

JUL 31, 2026 · REGULATORY LABEL UPDATE

FDA supplemental approval: Rosuvastatin Calcium (Labeling)

U.S. Food and Drug Administration

FDA supplemental approval of labeling changes for generic rosuvastatin calcium; does not contain clinical trial data or efficacy evidence.

JUL 29, 2026 · REGULATORY LABEL UPDATE

FDA supplemental approval: Tacrolimus (Labeling)

U.S. Food and Drug Administration

FDA supplemental approval of tacrolimus labeling by Alkem Labs; this is a regulatory action record without clinical trial data and does not support efficacy or comparative clinical claims.

JUL 29, 2026 · REGULATORY LABEL UPDATE

FDA supplemental approval: Mycophenolate Mofetil (REMS)

U.S. Food and Drug Administration

FDA supplemental approval for mycophenolate mofetil REMS; this is a regulatory action, not a clinical evidence assessment.

JUL 29, 2026 · REGULATORY LABEL UPDATE

FDA supplemental approval: Mycophenolic Acid (REMS)

U.S. Food and Drug Administration

FDA supplemental approval for REMS (Risk Evaluation and Mitigation Strategy) on mycophenolic acid formulations; this is a regulatory action, not a clinical efficacy study.

JUL 16, 2026 · REGULATORY LABEL UPDATE

FDA supplemental approval: Ibuprofen AND Famotidine (Labeling)

U.S. Food and Drug Administration

FDA supplemental approval for labeling of a fixed-dose combination product; regulatory action does not contain clinical trial data or efficacy evidence.

APR 23, 2026 · REGULATORY LABEL UPDATE

FDA supplemental approval: Olmesartan Medoxomil AND Hydrochlorothiazide (Labeling)

U.S. Food and Drug Administration

FDA supplemental approval of a labeling change for an existing combination antihypertensive; does not contain clinical trial data or efficacy evidence.

APR 2, 2026 · REGULATORY LABEL UPDATE

FDA supplemental approval: Gabapentin (Labeling)

U.S. Food and Drug Administration

FDA supplemental approval action for gabapentin labeling; documents regulatory decision but does not report clinical trial data or efficacy evidence.