Accutane Attorneys
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
Rockville, MD 20857
NDA 18-662/S-056
Hoffman La-Roche
Attention: Ellen Carey, Senior Program Manager
340 Kingsland Street
Nutley, New Jersey 07110-1199
Dear Ms Carey:
Please refer to your supplemental new drug application dated February 20, 2004, received February 24, 2004, submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act for Accutane (isotretinoin) Capsules, 10 mg, 20 mg and 40 mg.
This supplemental new drug application provides for the following labeling revisions:
1. Black Box CONTRAINDICATIONS and WARNINGS: Addition of “(see PRECAUTIONS:
Drug Interactions)” following “A drug interaction that decreases effectiveness of hormonal
contraceptives has not been entirely ruled out for Accutane”.
2. PRECAUTIONS: Drug Interactions: Addition of the following bullet:
Norethindrone/ethinyl estradiol: In a study of 31 premenopausal women with severe
recalcitrant nodular acne receiving OrthoNovum? 7/7/7 Tablets as an oral contraceptive agent, Accutane at the recommended dose of 1 mg/kg/day, did not induce clinically relevant changes in the pharmacokinetics of ethinyl estradiol and norethindrone and in the serum levels of progesterone, follicle-stimulating hormone (FSH) and luteinizing hormone (LH).
3. Addition of the statement “OrthoNovum 7/7/7 is a registered trademark of Ortho-McNeil
Pharmaceutical, Inc.” at the end of the package insert.
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 agreed-upon labeling text.
The final printed labeling (FPL) must be identical to the enclosed labeling (text for the Package Insert, text for the Patient Information/Consent (for female patients concerning birth defects), Informed Consent/Patient Agreement (for all patients), and the text for the Medication Guide).
Please submit the FPL electronically according to the guidance for industry titled Providing Regulatory Submissions in Electronic Format – NDA. Alternatively, you may submit 20 paper copies of the FPL as soon as it is available, in no case more than 30 days after it is printed. Please individually mount 15 of the copies on heavy-weight paper or similar material. For administrative purposes, this submission should be designated “FPL for approved supplement NDA 18-662/S-054”. Approval of this submission by FDA is not required before the labeling is used.
In addition, submit three copies of the introductory promotional materials that you propose to use for this product. Submit all proposed materials in draft or mock-up form, not final print. Send one copy to this division and two copies of both the promotional materials and the package inserts directly to:
Division of Drug Marketing, Advertising, and Communications, HFD-42
Food and Drug Administration
5600 Fishers Lane
Rockville, MD 20857
If you issue a letter communicating important information about this drug product (i.e., a “Dear Health Care Professional” letter), we request that you submit a copy of the letter to this NDA and a copy to the following address:
MEDWATCH, HFD-410
FDA
5600 Fishers Lane
Rockville, MD 20857
We remind you that you must comply with reporting requirements for an approved NDA (21 CFR 314.80 and 314.81).
If you have any questions, call Kalyani Bhatt, Regulatory Project Manager, at (301) 827-2020.
Sincerely,
Jonathan K. Wilkin, M.D.
Director
Division of Dermatologic and Dental Drug Products
Office of Drug Evaluation V
Center for Drug Evaluation and Research
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