FDA Corrects Notice on Withdrawal of Approval for Seven Abbreviated New Drug Applications

Summary

The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register on March 5, 2021, regarding the withdrawal of approval for seven abbreviated new drug applications (ANDAs) from multiple applicants, including Neopharma, Inc., as of April 5, 2021. The FDA had withdrawn approval for five ANDAs after receiving a withdrawal request from Neopharma, Inc., but later reinstated approval for five of the ANDAs after Neopharma, Inc. timely requested that the approval not be withdrawn.