Business · 03/10/2019Updated: 10/17/2026 · 1 min read
Teva Pharmaceuticals USA, Inc., et al.; Withdrawal of Approval of Five Abbreviated New Drug Applications for Pemoline Products; Correction
Summary
The FDA is correcting a notice that withdrew approval of five abbreviated new drug applications for pemoline products due to incorrect information regarding a 2005 FDA communication about the liver toxicity risk of CYLERT and generic pemoline products.
Original source language: Federal Register — Food and Drug AdministrationOpen original release →