Business · 22/11/2010Updated: 10/17/2026 · 1 min read

FDA Withdraws Approval of ACCUTANE Drug Application by Hoffmann-La Roche Inc.

Summary

The FDA is withdrawing approval of a new drug application for ACCUTANE (isotretinoin) Capsules, submitted by Hoffmann-La Roche Inc., due to the drug product no longer being marketed. Hoffmann-La Roche Inc. made this request in writing.

Original source language: Federal Register — Health and Human ServicesOpen original release →

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