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 An IND for Aetoxisclerol was submitted and withdrawn in 1979.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