Teva Pharmaceuticals USA, Inc., et al.; Withdrawal of Approval of Five Abbreviated New Drug Applications for Pemoline Products; Correction

摘要

The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register of June 4, 2019. That notice, withdrawing approval of five abbreviated new drug applications for pemoline products, contained an incorrect website address for an archived web page of a Postmarket Drug Safety Information for Healthcare Professionals communication that FDA issued on October 24, 2005, stating its conclusion that the overall liver toxicity risk of CYLERT (new drug applications 016832 and 017703) and generic pemoline products outweighed the benefits of these products. This document corrects that error.