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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
Rockville, MD 20857
NDA 18-662/S-059
Hoffman La-Roche, Inc.
Attention: Maryann Major Senior Program Manager, Drug
Regulatory Affairs
340 Kingland Street
Nutley, NJ 07110
Dear Ms. Major:
Please refer to your supplemental new drug application
dated June 24, 2008, received June 27, 2008, submitted
under section 505(b)(1) of the Federal Food, Drug, and
Cosmetic Act for Accutane® (isotretinoin) Capsules.
This supplemental new drug application provides for
a revision to the Medication Guide to add the toll-free
number for reporting adverse events to FDA per the Food
and Drug Administration Amendments Act of 2007.
We completed our review of this application, as amended.
This application is approved, effective on the date
of this letter, for use as recommended in the enclosed
agreed-upon labeling text.
If you have any questions, call Catherine Carr, Regulatory
Project Manager, at (301) 796-2311.
Sincerely,
Susan J. Walker, M.D., F.A.A.D.
Director Division of Dermatology and Dental Products
Office of Drug Evaluation III Center for Drug Evaluation
and Research
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