Hospira, Inc., et al.; Withdrawal of Approval of Eight Abbreviated New Drug Applications; Correction

概要

The Food and Drug Administration (FDA) is correcting a notice entitled "Hospira, Inc., et al.; Withdrawal of Approval of Eight Abbreviated New Drug Applications" that appeared in the Federal Register of June 2, 2023. The document announced the withdrawal of approval (as of July 3, 2023) of eight abbreviated new drug applications (ANDAs) from multiple applicants. The document indicated that FDA was withdrawing approval of ANDA 077029, Calcipotriene Solution, 0.005% after receiving a withdrawal request from Tolmar, Inc., 701 Centre Ave., Fort Collins, CO 80526. Before FDA withdrew the approval of this ANDA, Tolmar, Inc. informed FDA that it did not want the approval of the ANDA withdrawn. Because Tolmar, Inc. timely requested that approval of ANDA 077029 not be withdrawn, the approval is still in effect. This document corrects that error.