FDA Corrects Notice on Withdrawal of 44 New Drug Applications and 158 Abbreviated New Drug Applications

Summary

The Food and Drug Administration (FDA) is correcting a notice that incorrectly announced the withdrawal of approval of 44 new drug applications and 158 abbreviated new drug applications from multiple applicants, effective November 3, 2016, due to an error in including a specific abbreviated new drug application (ANDA) for Pemoline Tablets held by Mallinkrodt Pharmaceuticals, LLC.