Accutane Attorneys
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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