Business · 29/11/2017Updated: 10/17/2026 · 1 min read
FDA Withdraws Approval of Roxane's ROXICODONE Sustained-Release Tablets
Summary
The Food and Drug Administration (FDA) is withdrawing its approval of a new drug application for Roxane Laboratories' ROXICODONE sustained-release tablets in two strengths, following the company's request. Roxane waived its right to a hearing on the matter.
Original source language: Federal Register — Food and Drug AdministrationOpen original release →