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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
Rockville, MD 20857
NDA 18-662/S-058
Hoffman La-Roche
Attention: MaryAnn Major, Senior Program Manager
340 Kingsland Street
Nutley, New Jersey 07110-1199
Dear Ms. Major:
Please refer to your pending supplemental new drug application
submitted February 16, 2007, received February 17, 2007
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 submissions dated April
24, May 22, September 11 and 20,
2007.
This supplemental application, considered for approval
under 21 CFR 314.520 (Subpart H),
proposed changes to the iPLEDGE program, an enhanced
risk minimization action plan
(RiskMAP) designed to minimize drug exposure during
pregnancy.
We have completed the review of this supplemental application,
as amended, and have
concluded that adequate information has been presented
to approve the supplemental application for Accutane
(isotretinoin) capsules, 10mg, 20mg, and 40mg. Accordingly,
this supplemental application is approved under 21CFR
314.520 (Subpart H). Approval is effective on the date
of this letter for use as recommended in the agreed
upon labeling text (attached) and the components of
the iPLEDGE RiskMAP.
We remind you that your Accutane RiskMAP (called iPLEDGE)
is an important part of the
postmarketing risk management for Accutane, and must
include each of the following
components:
1. Registration in the iPLEDGE program of wholesalers,
prescribers, pharmacies, and
patients who agree to accept specific responsibilities
in order to distribute, prescribe,
dispense, and use Accutane.
2. Implementation of a program and distribution of materials
to educate wholesalers,
prescribers, pharmacists, and patients about the risks
and benefits of Accutane.
3. Implementation of a reporting and data collection
system for: a) serious adverse events
associated with the use of Accutane that complies with
the reporting requirements for an
approved NDA (21 CFR 314.80 and 314.81) and b) sales
and dispensing of Accutane
outside of the iPLEDGE program.
4. Implementation of a plan to monitor, evaluate, and
improve minimization of drug
exposure during pregnancy and compliance with restrictions
for safe use under the
iPLEDGE program. A component of the evaluation program
includes a pregnancy
registry to elucidate the root cause of potential RiskMAP
failure.
The iPLEDGE program approved on August 12, 2005, along
with the changes to the iPLEDGE
program, as described in the attached document, adequately
addresses each of these
requirements. We remind you that any change to the program
must be discussed with FDA prior to its institution
and is subject to FDA's determination that the required
components continue to be met.
FDA will re-evaluate the adequacy of the iPLEDGE program
on a continuing basis regarding its success in achieving
the goal of minimizing drug exposure during pregnancy
and adherence to program components.
The final printed labeling (FPL) must be identical to
the agreed upon labeling text submitted
September 20, 2007. Marketing the product with FPL with
text that is not identical to the
approved text may render the product misbranded and
an unapproved new drug.
If you have any questions, please call Kalyani Bhatt,
Regulatory Project Manager, at (301) 796- 2110.
Sincerely,
Susan J. Walker, MD, FAAD
Director
Division of Dermatology & Dental Products
Office of Drug Evaluation III
Center for Drug Evaluation and Research
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