High Chemical Co. et al.; Proposal to Withdraw Approval of 13 New Drug Applications; Opportunity for a Hearing; Reissuance

Короткий зміст

The Food and Drug Administration (FDA) is reissuing the notice announcing an opportunity to request a hearing on the agency's proposal to withdraw approval of 13 new drug applications (NDAs) from multiple sponsors. The basis for the proposal is that the sponsors have repeatedly failed to file required annual reports for these applications. In the Federal Register of January 28, 2005 (70 FR 4134), FDA published a notice announcing an opportunity for a hearing on the agency's proposal to withdraw approval of 13 NDAs from multiple sponsors. That notice published with an inadvertent error; in a document published elsewhere in this issue of the Federal Register, the agency is withdrawing that notice.