Apotex

SEP 2, 2026 · SAFETY RECALL

Class II recall: Paxil CR, Paroxetine, Extended-Release Tablets, 37.5mg, 30 count bottle, Rx only, Manufactured by: Apotex Inc., Toronto, Ontario, Canada M9L 1T9, Manufactured f

U.S. Food and Drug Administration

FDA Class II recall of Paxil CR 37.5 mg due to failed dissolution specifications and stability testing; affects product quality and bioavailability but does not report clinical outcomes.

JUL 1, 2026 · REGULATORY LABEL UPDATE

FDA supplemental approval: Azelastine Hydrochloride AND Fluticasone Propionate (Labeling)

U.S. Food and Drug Administration

FDA supplemental approval of labeling for an established nasal spray combination; documents a regulatory action rather than new clinical evidence.

JUN 24, 2026 · REGULATORY LABEL UPDATE

FDA supplemental approval: Imiquimod (Labeling)

U.S. Food and Drug Administration

FDA supplemental approval for imiquimod labeling update; regulatory action record containing no clinical trial data or efficacy comparisons.

JUN 3, 2026 · REGULATORY APPROVAL

FDA approval: Tofacitinib

U.S. Food and Drug Administration

FDA approval of a generic tofacitinib formulation; regulatory action does not convey clinical trial evidence or comparative efficacy.

MAY 28, 2026 · REGULATORY LABEL UPDATE

FDA supplemental approval: Carbidopa AND Levodopa (Labeling)

U.S. Food and Drug Administration

FDA supplemental approval of labeling changes for an established combination product; does not report clinical trial outcomes or comparative efficacy.

MAY 20, 2026 · REGULATORY LABEL UPDATE

FDA supplemental approval: Brimonidine Tartrate (Labeling)

U.S. Food and Drug Administration

FDA supplemental approval for labeling of an established ophthalmic agent; documents regulatory action without reporting clinical trial outcomes or comparative efficacy data.

MAY 12, 2026 · REGULATORY APPROVAL

FDA approval: Everolimus

U.S. Food and Drug Administration

FDA approval of a generic everolimus formulation; confirms regulatory clearance but does not report clinical efficacy or comparative trial data.

MAY 1, 2026 · REGULATORY APPROVAL

FDA approval: Evdi (Type 5 - New Formulation or New Manufacturer)

U.S. Food and Drug Administration

FDA approval of a new formulation/manufacturer of trabectedin; this is a regulatory action record without clinical trial data or efficacy comparisons.