FDA clears three labeling supplements for palonosetron, letrozole, carbamazepine
Three generic drug applications received standard-priority labeling supplement approvals in the same week.
The FDA approved labeling updates for three long-established generic products in the week ending September 17, 2026.
- Teva Pharms USA's palonosetron hydrochloride injectable (ANDA090713) received a supplement 3 labeling approval, covering two intravenous strengths1, with the status dated September 17, 2026.
- Actavis Totowa's letrozole 2.5MG oral tablet (ANDA090292) received a supplement 1 labeling approval2, dated September 15, 2026.
- Teva Pharms' extended-release carbamazepine capsules (ANDA078592), available in 100MG, 200MG, and 300MG strengths, received a supplement 6 labeling approval3, also dated September 15, 2026.
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