BN Business News
Add your company to Business Communicator →

Business · 04/06/2019Updated: 10/17/2026 · 1 min read

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

Summary

The US Food and Drug Administration (FDA) is revoking the approval of five abbreviated new drug applications for medications containing pemoline, following a request from the applicants to withdraw the applications and waive a hearing process.

Original source language: Federal Register — Food and Drug AdministrationOpen original release →

Explore insights

Business insights →