Notice of Opportunity To Withdraw Abbreviated New Drug Applications To Avoid Backlog Fee Obligations

Résumé

The Food and Drug Administration (FDA) is issuing this notice to provide applicants who are no longer seeking approval of their pending original abbreviated new drug applications (ANDAs) with an opportunity to withdraw them as soon as possible to avoid paying a fee. The fee in question is a one-time backlog fee that was established through enactment of the Generic Drug User Fee Amendments of 2012 (GDUFA). It will apply to any original ANDA that is pending (neither withdrawn nor tentatively approved) at FDA on October 1, 2012. This notice is intended to allow applicants to decide which ANDAs they do not wish to pursue and by timely notice of withdrawal avoid paying the new backlog fee on such applications.