DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
Rockville MD 20857
NDA 19-983/S-016
Elan Pharmaceutical Research Corporation
Attention: Roger Wayne Wiley, R.Ph.
Director, North America Regulatory Affairs
1300 Gould Drive
Gainesville, GA 30504
Dear Mr. Riley:
Please refer to your supplemental new drug application dated November 1, 2001, received
November 2, 2001, submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act for
Prostep (11 mg/day and 22 mg/day nicotine transdermal patch).
This “Changes Being Effected” supplemental new drug application provides for labeling changes
requested in our letters addressed to supplemental application S-012, dated May 24, 2001, and
August 17, 2001.
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 submitted final printed labeling (immediate pouch and carton labels and patient
information leaflet submitted November 1, 2001). Accordingly, the supplemental application is
approved effective on the date of this letter.
We have the following recommendations for your consideration. These recommendations should be
incorporated at the next printing or within 180 days, whichever comes first, and should be submitted in
a “Changes Being Effected” supplemental application to this NDA.
1. Revise the “Drug Facts” carton labeling as follows.
a.
On the 11 mg and 22 mg refill cartons, change the heading from “Uses” to “Use” and
revise this section in all labeling to read, “Use reduces withdrawal symptoms,
including nicotine craving, associated with quitting smoking”.
b.
Under the subheading Warnings, Ask a doctor or pharmacist before use if you are:
(i)
Add as the first bullet, “using a non-nicotine stop smoking drug”.
(ii) Delete the bulleted phrase, “under 18 years of age”.
NDA 19-983/S-016
Page 2
c.
Under the heading Directions:
(i)
Add, in bold type