Final Decision on Withdrawal of PEPAXTO (melphalan flufenamide) Following Appeal of the Proposal To Withdraw Approval; Availability of Final Decision

Zusammenfassung

The Food and Drug Administration (FDA or Agency) is announcing the availability of the final decision withdrawing approval of PEPAXTO (melphalan flufenamide), for injection, equivalent to 20 milligrams (mg) base/vial, once every 28 days, under the new drug application (NDA) 214383, held by Oncopeptides AB (Oncopeptides). The Commissioner of Food and Drugs' (the Commissioner's) designee issued the decision, and a summary of responses to public comments. The Commissioner's designee issued this decision following the Center for Drug Evaluation and Research's (CDER) proposal to withdraw approval of PEPAXTO, Oncopeptides' appeal of the proposed withdrawal, a meeting between the designee and Oncopeptides, a public comment period on the proposed withdrawal, and an advisory committee that CDER convened and consulted on issues related to the proposed withdrawal.