Historical Information on Isotretinoin (marketed as Accutane)

• iPLEDGE Update, March 22, 2006

• iPLEDGE Program Frequently Asked Questions As of July 21, 2006.  These FAQs have been provided by Covance, Inc., contractor for the sponsors of isotretinoin.  (updated 8/15/2006) 

• Questions and Answers on Accutane (11/23/2004)
• Medication Guide (see page 31) [PDF]  (5/2002)
• FDA Labeling Supplement Approval Letter [PDF] (2/21/2002)
• Advisory Committee Meeting Transcripts

 

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.