Historical Information on Isotretinoin (marketed as Accutane)
Many of these items are out-of-date.
Adverse reactions or quality problems experienced with the use of this Product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax, using the contact information at the bottom of this page.
Isotretinoin (marketed as Accutane) Capsule Information
iPLEDGE March 2006 Update
iPLEDGE Program Frequently Asked Questions As of July 21, 2006(PDF - 68KB)
These FAQs have been provided by Covance, Inc., contractor for the sponsors of isotretinoin. (updated 8/15/2006)
Accutane (isotretinoin) Questions and Answers
Accutane - Medication Guide 5/2002 Accutane - FDA Labeling Supplement Approval Letter
Accutane - Advisory Committee Meeting Transcripts