Federal Register Notice: FDA is withdrawing approval of 128 suitability petitions in accordance with the Pediatric Research Equity Act of 2003 (PREA) because ANDAs were never submitted and PREA requires that all applications submitted on or after 4/1/99, for a new active ingredient, new indication, new dosage form, new dosing regimen, or new route of administration contain an assessment of the safety and effectiveness of the drug for the claimed indications in relevant pediatric subpopulations unless the requirement is waived or deferred.

Prior to PREA's enactment, FDA had approved these suitability petitions to permit ANDAs to be submitted for drugs that had a different active ingredient, dosage form, or route of administration than their reference listed drugs. To view this notice, click here.