IA #66-49 - Revised 10/5/92, "Automatic Detention of Polidocanol
          Brand Names Aetoxisclerol and Aethoxysklerol"



TYPE OF ALERT: Automatic Detention

PRODUCT      : Polidocanol - also known as

               - aetoxisclerol 0.5%
               - aethoxysklerol injection 1% and 3%


PRODUCT CODE : 66 [][][][][]

HARMONIZED
CODE         : N/A

PROBLEM      : Unapproved New Drug (DNRD)
               Mandatory Labeling Omitted (MLLM)

PAC FOR
COLLECTION   : 56008H

COUNTRY      : France (FR, 350)
               Germany (GE, 394)

MANUFACTURER/
SHIPPER      : See attachment

MANUFACTURER/
SHIPPER I.D.#: N/A


IMPORTER'S
I.D. #       : N/A

CHARGE       : "The article is subject to refusal of admission
               pursuant to Section 801(a)(3) in that it appears
               to be a new drug within the meaning of 201(p),
               without an approved new drug application (NDA)
               [Unapproved New Drug; Section 505(a)]

                              and
               its labeling fails to bear required information in
                the English language [Misbranded; 502(c)]."


RECOMMENDING
OFFICE       : DAL-DO and DET-DO

REASON FOR
ALERT        : The drug, Aetoxisclerol (Polidocanol) is being
               brought into the U.S. by private physicians for
               the treatment of spider veins.  An IND for
               Aetoxisclerol was submitted and withdrawn
               in 1979.  More recently, an IND for Polidocanol
               was submitted but was placed on clinical hold.
               Aetoxisclerol, manufactured by Laboratoires
               Pharmacetiques, has been identified as labeled
               solely in French.

INSTRUCTIONS : Detain, without sampling, all shipments of the
               unapproved investigational new drug, Polidocanol,
               to determine if it is covered by a currently
               active IND.  The product has been shipped under
               the name of Aetoxisclerol from Laboratoires
               Pharmacetiques and under the name of
               Aethoxysklerol from Kreussler and Company,
               Germany.  However, additional brands
               may be available from other foreign manufacturers.
               Additional questions regarding INDs should be
               directed to HFD-161, 443-3560.

PRIORITIZATION
GUIDANCE     : N/A

FOI          : No purging required

KEYWORDS     : Polidocanol, Aetoxisclerol, Aethoxysklerol,  Unapp
                                                            roved
                                                            New
                                                            Drug,
                                                            IND,
                                                            NDA

PREPARED BY  : Rosa K. Forehand, DIOP, 301-443-6553.




                     Attachment to Import Alert #66-49 4/22/03


               MANUFACTURERS/SHIPPERS ON AUTOMATIC DETENTION


Manufacturer/Shipper                         Product


Laboratoires Pharmacetiques                  Aetoxisclerol 0.5%
Dexo, S.A.
31 Rue d'Arras
92000 Nanterre, France

Kreussler and Company, GmbH                  Aethoxysklerol 1%
(injection)
Wiesbaden - Biebrich                         Aethoxysklerol 3%
(injection)
Germany

          Shippers: Iuvabec Inc.
                     and Omega
                    11 177 Hamon
                    Montreal, Quebec,
                    Canada, H3M 3E4


(Manufacturer)
Resinag Ag                         "Sclerovein" brand of
Unknown address                    Polidocanol, 5%; 30 ml ampule
Schwyz, Switzerland                66R- -99
FEI #3000938540                    4/22/03

Resinag Ag
Dorfstrasse 143
Kilchberg, Switzerland
FEI #3003361265

(Shipper)
V.S. Ltd.
Suite 1, Six Ways House
15 Sutton New Road
Erdington, Birmingham, England
FEI #3003075613