IA#60-01 --- 2/24/87
BACKGROUND
Minneapolis and Detroit districts recently reported activity in the
importation of Canadian Tagamet. Detroit district refused entry of a shipment
of Canadian Tagamet which was consigned to Crosstown Drug, Hamlake, Minnesota.
We were previously aware that shipments had entered through Portland, Oregon
and Murfreesboro, Tennessee, while Buffalo, Boston, and Nashville districts
had previously detained attempted entries. There is reason to believe that
there may be attempts to enter Canadian Tagamet through other U.S. ports of
entry as well.
Smith, Kline & French Laboratories (USA) is concerned about such illegal
importations and they are making every effort to stop them. Smith, Kline &
French, Canada Ltd., has not been implicated in the illegal importation. Two
shippers that have been identified, Speedway Drugs, Edmonton, Alberta, Canada,
and National Drug Ltd., Winnipeg, Manitoba, Canada, (shipper of product to
Crosstown Drug) are wholesalers who do not purchase directly from the
manufacturer, but from other wholesalers.
Tagamet manufactured in Canada, is considered a new drug which may only be
imported/marketed in this country pursuant to an approved new drug application
(NDA). No such approval has been granted, nor is any application for approval
on file for the Canadian facility.
The unapproved product is produced by:
Smith, Kline & French, Canada Ltd.
1940 Argentina Road
Mississauga (Toronto) Ontario
The identifying features of the package are:
1) Generally packed in bottles of 1000 tablets:
2) The name of the manufacturer, Smith, Kline & French, Canada Ltd., and
directions for use appear on the label in English and French;
3) The label fails to bear a NDC number, nor is there an insert attached to
the package:
4) The label bears a number required by the Canadian Government, known as a
DIN number, which for Tagamet 300 mg tablet is DIN #397474:
5) Tagamet (Canadian) is the same color, size, and shape as the American
version, but the tablet markings are different as follows:
American Tagamet Canadian Tagamet
Tagamet 300 SKF
SKF T13
Tagamet 200 SKF
SKF T12
While we have no information that there is any effort to import generic
cimetidine manufactured in Canada, you should be aware that there are three
Canadian manufacturers for the generic drug product, two of which have the
same light green color as the American product. However, because of
significant price differential, an attempt may be made to import the generic
product. We therefore, include the following information for your records.
Available
Manufacturer Product Name Strength Tablet Markings
All strengths light green color
Apotex, Inc. APO-Cimetidine 300 mg Marked APO 300
406 Ormont Dr. Tablet 200 mg Marked APO 200
All strengths light green color
NovoPharm Nova Cimetidine 300 mg Marked NOVO 300
1290 Ellsmere Tablet 200 mg Marked NOVO 200
Rd. Scarborough
Toronto, Canada
Horner Labs Ltd. Pettol Tablet 300 mg 300 mg - blue color
5485 Ferrier St. Marked FWH
Montreal, Canada 300
200 mg 200 mg - yellow color
Marked FWH
200
GUIDANCE:
Increased surveillance is indicated for SKF's Tagamet Tablets (all strengths)
and Cimetidine Tablets (all strengths) produced in Canada. If they are
encountered, detain, charging:
"The article is violative within the meaning of section 801(a) (3)
of the Federal Food, Drug, and Cosmetic Act in that it appears to
be a new drug without an approved new drug application (NDA)
pursuant to section 505."
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