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Hoffman-La Roche, Inc.
Attention: Joanna Waugh, BSc, Hons.
Group Director, Drug Regulatory Affairs
340 Kingsland Street
Nutley, New Jersey 07110
Dear Ms. Waugh:
Please refer to your supplemental new drug application
dated May 23, 2002, received
May 24, 2002, submitted under section 505(b) of the
Federal Food, Drug, and Cosmetic Act for Accutane (isotretinoin)
Capsules, 10 mg, 20 mg, and 40 mg.
We acknowledge receipt of your submission dated June
11, 2002.
Supplemental new drug application S051 provides for
the addition of a Pregnancy Testing Table to the Boxed
Warning section, and additional wording listing aggressive
and/or violent behaviors in the WARNINGS, and ADVERSE
REACTIONS sections, Informed Consent, and Medication
Guide of the label, and the blister pak container.
We have completed the review of this supplemental application,
and have concluded that
adequate information has been presented to demonstrate
that the drug product is safe and
effective for use as recommended in the agreed upon
enclosed labeling text. Accordingly, this supplemental
application is approved effective on the date of this
letter.
We also note your agreement to revising with the next
printing, the Prescriber’s Brochure,
“Recognizing Psychiatric Disorders In Adolescent
and Young Adults” with the additional
wording of aggressive and/or violent behavior, as well
as to issue a “Dear Health Care
Professional Letter” which conveys all of the
most recent labeling approval information (S043 and
S051).
The final printed labeling (FPL) must be identical to
the enclosed labeling text. Please submit
the copies of final printed labeling (FPL) electronically
according to the guidance for industry
titled Provide Regulatory Submissions in Electronic
Format – NDA (January 1999).
Alternatively, you may submit 20 paper copies of the
FPL as soon as it is available but no more than 30 days
after it is printed. Please individually mount ten 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/S051”. Approval of this submission by the
FDA is not required before the labeling is used.
When the “Dear Health Care Professional Letter”
communicating the important information
about this drug product is issued to physicians and
others responsible for patient care, we request that
you submit a copy of the letter to this NDA and a copy
to the following address:
MEDWATCH, HF-2
FDA
5600 Fishers Lane
Rockville, MD 20857
We remind you that you must comply with the requirements
for an approved NDA set forth
under 21 CFR 314.80 and 314.81.
If you have any questions, call Kalyani Bhatt, 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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