NDA
21-515
Page
3
dispensing for various reasons. Wellbutrin XL will be supplied in bottles of 30 as 150 mg or 300 mg tablets. Even if the PPI is packaged with these bottles, the following factors may diminish the percentage of patients receiving a PPI. The dose of Wellbutrin XL ranges from 150 mg to 450 mg per day. Pharmacies may repackage medications from these packaged amounts when the prescribed amount differs from the package amount, or when they have a low supply of the medication on hand and can only dispense a partial prescription.
We
have not completed validation of the regulatory methods. However, we expect your continued
cooperation to resolve any problems that may be identified.
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/the Division
of Neuropharmacological Drug 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
The
MedWatch-to-Manufacturer Program provides manufacturers with copies of serious
adverse event reports that are received directly by the FDA. New molecular entities and important new
biologics qualify for inclusion for three years after approval. Your firm is eligible to receive copies of
reports for this product. To
participate in the program, please see the enrollment instructions and program
description details at www.fda.gov/medwatch/report/mmp.htm.
We remind you that you must comply with reporting requirements for an approval. NDA (21 CFR 314.80 and 314.81).
If
you have any questions, call Doris J. Bates, Ph.D., Regulatory Project Manager,
at (301) 594-2850.
Sincerely,
{see appended electronic signature page}
Russell Katz, M.D.
Director
Division of Neuropharmacological Drug Products
Office of Drug Evaluation I
Center for Drug Evaluation and Research
Enclosure
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