Business · 16/08/2017Updated: 10/17/2026 · 1 min read
FDA Withdraws Approval of Zaleplon Capsules by Upsher-Smith Laboratories
Summary
The FDA has withdrawn approval of an abbreviated new drug application for Zaleplon Capsules, 5mg and 10mg, submitted by Upsher-Smith Laboratories, following the company's voluntary request to withdraw the application and waive a hearing.
Original source language: Federal Register — Food and Drug AdministrationOpen original release →