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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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