IA#68-08 --- 2/10/87
BACKGROUND
The Center for Veterinary Medicine has received reports that the following
drugs are being used illegally in race horses in this country:
1. Healon Injection or Hylartin V (Hyaluronic Acid or Sodium
Hyaluronate)
2. Arteparon (Glucosaminoglycan Polysulfuric Acid Ester)
3. Clenbuterol
4. Domosedan (Detomidine hydrochloride)
5. Circulon (Isoxsuprine hydrochloride)
We routinely receive complaints from state race track authorities about the
illegal use of these drugs. Although we are not sure exactly how these drugs
enter the country, we suspect they enter in small lots which escape detection.
All of these drugs may legally enter when consigned to the holder of a valid
INAD or approved NADA. Any product entering which does not conform to the
requirements of an NADA/INAD must be denied entry. Following are the
specifics of the appropriate NADA/INAD.
Hylartin V or Healon Injection (Hyaluronic Acid or Sodium
hyaluronate) (approved NADA 112-048)
Pharmacia AB, Uppsala, Sweden, is the only source of hyaluronic acid
provided for in the approved NADA. Pharmacia Inc., Piscataway, New
Jersey is the sponsor named in the NADA. Any hyaluronic acid in import
status not from Pharmacia and not going to Piscataway, New Jersey, should
be denied entry.
According to our information, most of the illegal entries of hyaluronic
acid originate in Italy. Pitman-Moore also holds an INAD for hyaluronic
acid (HYVISC) but they do not receive shipments from foreign sources.
Arteparon (glycosaminoglycan polysulfated ester) - This is a human
labeled product produced by Luitpold-Werk, Munich, West Germany, being
brought into the U.S. illegally for use in race horses. There is an
approved NADA 136-383 for the same drug under the trade name Adequan
manufactured by the same German firm. The U.S. sponsor is Dr. Lawrence
Goldman, Jupiter, Florida.
Clenbuterol (INAD 2227)
Bohringer Ingelheim Ltd., in Germany is the only source of Clenbuterol
provided for in the INAD. Philips Roxanne, Inc., 2621 North Belt
Highway, St. Joseph, MO, is the sponsor named in the INAD. Clenbuterol
should not be coming from any other source or going to any other
consignee. Any Clenbuterol in import status not conforming to the above
should be denied entry.
Domosedan (Detomidine Hydrochloride) (INAD 2956)
Domosedan is the trade name of the product approved in England and
Finland. Wolfgang Jochle Associates, Inc., Denville, New Jersey, holds
the INAD on behalf of the Farmos Group Ltd., Turku, Finland. Any
detomidine hydrochloride not consigned to Wolfgang Jochle Associates
should be detained.
Circulon (Isoxsuprine Hydrochloride) (INAD 2912)
Circulon is the trade name of the product approved in Australia. Ceva
Labs, Overland Park, Kansas is the U.S. Sponsor of Circulon under this
INAD. The legal drug is sent to Ceva Labs by Medical Research Pty. Ltd.,
Sydney, Australia. Any entries of Isoxsuprine hydrochloride not
consigned to Ceva should be detained.
GUIDANCE
If any of these veterinary drugs are offered for import by any supplier other
than the approved source and/or consigned to other than the approved sponsor,
they should be detained charging: "The article is adulterated within the
meaning of section 801(a)(3) in that it appears to be a new animal drug within
the meaning of section 201(w) which is adulterated within the meaning of
501(a)(5)."
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