Novitium Pharma

AUG 11, 2026 · REGULATORY LABEL UPDATE

FDA supplemental approval: Glipizide AND Metformin Hydrochloride (Labeling)

U.S. Food and Drug Administration

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

JUL 21, 2026 · REGULATORY APPROVAL

FDA approval: Pitolisant Hydrochloride

U.S. Food and Drug Administration

FDA approval of pitolisant hydrochloride oral tablets; this is a regulatory action record that does not contain clinical trial efficacy or safety data.

JUN 26, 2026 · REGULATORY APPROVAL

FDA approval: Tramadol Hydrochloride

U.S. Food and Drug Administration

This is an FDA approval action for a generic tramadol hydrochloride oral solution; it documents regulatory authorization but does not contain clinical trial data or efficacy evidence.

JUN 25, 2026 · REGULATORY LABEL UPDATE

FDA supplemental approval: Naproxen (Labeling)

U.S. Food and Drug Administration

This is an FDA supplemental approval for naproxen labeling; it documents a regulatory action but does not report clinical trial outcomes or efficacy data.

JUN 18, 2026 · REGULATORY LABEL UPDATE

FDA supplemental approval: Butalbital, Aspirin, Caffeine, AND Codeine Phosphate (REMS)

U.S. Food and Drug Administration

FDA supplemental approval action establishing REMS (Risk Evaluation and Mitigation Strategy) for a combination analgesic containing codeine; regulatory classification only, not a clinical efficacy study.