Strike three

FDA Proposes to Withdraw Applications – Failure to Submit Annual Reports

In a prepublication of the Federal Register today, the FDA announced its intentions to withdraw four NDAs (see chart below) for failure to submit required annual reports.  In the notice, the Agency noted the firms have been contacted by the Agency but have repeatedly failed to submit the required reports.  The Notice provides the firms with the opportunity to request a hearing prior to the Agency taking action to withdraw.

Such notices are not unusual, especially if the firms have discontinued marketing of the products for a period of time.  It is noted that three of the products are “vintage” with approval dates ranging from 1965 to 1995.  The Lidosite application is of newer ilk and was approved in 2004.

The Agency is proposing to withdraw the applications under Section 505(e) of the Federal Food Drug and Cosmetic Act (21 U.S.C. 355(e)) for continued failure to submit annual reports.