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U.S. Department of Health and Human Services

Animal & Veterinary

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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

Merial, Ltd.
(NADA 141-214)
Ivermectin/Praziquantel (Zimecterin® Gold)
Horses. For control of various internal parasites.
ORAL—The NADA provides for use of an ivermectin and praziquantel oral paste.
Federal Register 06/30/03

Boehringer Ingelheim Vetmedica, Inc.
(NADA 141-213)
Meloxicam (Metacam®) RX
Dogs. For the control of pain and inflammation.
ORAL—The NADA provides for use of meloxicam oral suspension for the control of pain and inflammation associated with osteoarthritis in dogs.
Federal Register 07/21/03

PR Pharmaceuticals, Inc.
(NADA 141-040)
Estradiol Benzoate (Celerin)
Steers and heifers. For increased rate of weight gain and improved feed efficiency.
SUBCUTANEOUS—The NADA provides for subcutaneous injection, in the ear only, of a suspension implant of estradiol benzoate microspheres.
Federal Register 08/19/03

PR Pharmaceuticals, Inc.
(NADA 141-041)
Estradiol Benzoate (Celerin C)
Suckling beef calves. For increased rate of weight gain.
SUBCUTANEOUS—The NADA provides for use of Celerin C, also microspheres for constitution, by subcutaneous injection, in the ear only, for increased rate of weight gain in suckling beef calves.
Federal Register 08/19/03z