FDA Publishes List of 249 ANDAs it Proposes to Withdraw

In the Federal Register pre-publication notices today, the FDA announced an opportunity for hearing for 249 ANDAs that it proposes to withdraw because the applicants have repeatedly failed to submit Annual Reports.  The notice announces the opportunity for a hearing for any of the applicants.  Many of the ANDAs are old applications, with some from companies that have been out of business for years; there are even some from firms that were caught up in the generic drug scandal where some of their applications had not yet been withdrawn but the companies are long gone.

Some, however, are for somewhat newer applications so check the list to be sure that none of your applications are on the chopping block.  You can halt the withdrawal and bring your application up to date by submitting the required Annual Reports.  Any request for hearing must be submitted thirty days from the publication in the FR, which will be on January 9th.  The full list of applications can be found here.