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U.S. Department of Health and Human Services


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Isotretinoin - Accutane and generic isotretinoin

Audience: Dermatological, other healthcare professionals and patients
[Posted 10/06/2006] FDA and the iPLEDGE program notified healthcare professionals and patients of an update to iPLEDGE, a risk management program to reduce the risk of fetal exposure to isotretinoin, that will eliminate one element of the program, the 23 day lock-out period for males and females of non-child bearing potential. This change does not affect female patients of child-bearing potential.

[October 06, 2006 - Letter - iPLEDGE Program]
[October 06, 2006 - Drug Information Page - FDA]
[October 06, 2006 - Questions and Answers - FDA]

Previous MedWatch alert:

[August 12, 2005]