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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
S-048 dated March 22, 2002, received March 25, 2002,
and S-052 dated May 15, 2003, received May 16, 2003,
submitted under section 505(b) of the Federal Food,
Drug, and Cosmetic Act for Accutane (isotretinoin) Capsules,
10 mg, 20 mg, and 40 mg.
Your submission for S-048 dated March 14, 2003, constituted
a complete response to our December 15, 2002 action
letter.
Supplemental new drug application S-048 provides for
the printed text and video storyboard presentation of
the submitted video on birth defects entitled: “Be
Aware: The Risk of Pregnancy While on Accutane”.
Supplemental new drug application S-052 provides for
revisions to the following: boxed CONTRAINDICATIONS
and WARNINGS section, Warnings (Lipids and Skeletal
subsection), PRECAUTIONS, Information for Patients and
Prescribers, Drug Interactions; Pediatric Use, boxed
Information for Pharmacists section; Patient Information/Consent
Form; System to Manage Accutane Related Teratogenicity
S.M.A.R.T. Guide to Best Practices; Be Smart Be Safe
Be Sure Accutane Pregnancy Prevention and Risk Management
Program for Women; Be Smart Be Safe Be Sure Accutane
(isotretinoin) Risk Management Program for Men; and
the Accutane Qualification Sticker.
We completed our review of these applications, as amended.
These applications are 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); Medication Guide; Accutane
Qualification Sticker; booklet for prescribers entitled
System to Manage Accutane Related Teratogenicity (S.M.A.R.T.)
Guide to Best Practices; Be Smart Be Safe Be Sure: Accutane
Pregnancy Prevention and Risk Management Program for
Women; Be Smart Be Safe Be Sure: Accutane (isotretinoin)
Risk Management Program for
Men; and printed text and video storyboard presentation
for the video entitled “Be Aware: The Risk of
Pregnancy While on Accutane”.
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-048 and S-052.” 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,
Division of Dermatologic and Dental Drug Products, and
two copies of both the promotional materials and the
package insert 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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