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U.S. Department of Health and Human Services

Animal & Veterinary

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Supplemental New Animal Drug Approvals - September/October 2003

FDA Veterinarian Newsletter September/October 2003 Volume XVIII, No 5

Company
Generic and (Brand) Names
Indications
Routes/Remarks

Alpharma, Inc.
(NADA 141-025)
Laidlomycin (Cattlyst®)
Cattle.
MEDICATED FEED—The supplement provides for use of CATTLYST Type A medicated articles used to formulate Type C medicated feeds for cattle and for the establishment of a tolerance at 0.2 parts per million for residues of laidlomycin in cattle livers. The previously established ADI for total residues of laidlomycin is also codified at 7.5 micrograms per kilogram of body weight per day.
Federal Register 07/18/03

Schering-Plough
Animal Health Corp.
(NADA 119-807)
Euthanasia Solution (Beuthanasia-D-Special) RX
Dogs. For humane, painless, and rapid euthanasia.
SUBCUTANEOUS OR INTRAMUSCULAR—The supplemental application provides for the addition of environmental warning statements to product labeling.
Federal Register 07/21/03

Merial, Ltd.
(NADA 134-314)
Ivermectin paste (Eqvalan® Paste 1.87%)
Horses. For treatment and control of internal parasites.
ORAL—The supplemental NADA provides for the addition of several new species of internal parasites to product labeling for ivermectin paste for horses.
Federal Register 07/22/03

Pfizer, Inc.
(NADA 141-199)
Carprofen (Rimadyl®)
Dogs. For the control of postoperative pain.
SUBCUTANEOUS—The supplemental NADA provides for use of carprofen solution in dogs, by subcutaneous injection, for the control of postoperative pain associated with soft tissue and orthopedic surgeries.
Federal Register 08/18/03