FDA Corrects Withdrawal of 20 Abbreviated New Drug Applications

Summary

The US Food and Drug Administration (FDA) has corrected a notice regarding the withdrawal of approval of 20 abbreviated new drug applications (ANDAs), including those for nitrofurantoin and duloxetine, which were initially set to be withdrawn on July 22, 2024, but were later reversed due to timely requests from the applicants, Aurobindo Pharma USA Inc. and Marksans Pharma, Inc.