FDA Corrects Notice on Withdrawal of 23 Abbreviated New Drug Applications

Summary

The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register on January 8, 2020, regarding the withdrawal of approval of 23 abbreviated new drug applications (ANDAs) from multiple applicants, including CASI Pharmaceuticals, Inc. The FDA initially withdrew approval of these ANDAs as of February 7, 2020, but later corrected the notice after receiving a request from CASI Pharmaceuticals, Inc. to reverse the decision.