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U.S. Department of Health and Human Services

Animal & Veterinary

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New Animal Drug Approvals - January/February 2004

FDA Veterinarian Newsletter January/February 2004 Volume XIX, No 1

Company
Generic and (Brand) Names
Indications
Routes/Remarks

Pharmacia & Upjohn Co.
(NADA 141-209)
Ceftiofur crystalline free acid sterile suspension
(NAXCEL XT) Rx
Beef and Non-lactating Dairy Cattle. For the treatment and control of bovine respiratory disease.

INJECTABLE — The NADA provides for the veterinary prescription use of ceftiofur crystalline free acid suspension in beef and non-lactating dairy cattle for the treatment of BRD (shipping fever, pneumonia) associated with Mannheimia haemolytica , Pasteurella multocida , and Haemophilus somnus and for the control of respiratory disease in cattle at high risk of developing BRD associated with M. haemolytica , P. multocida , and H. somnus .

Federal Register  10/22/03

Intervet, Inc.
(NADA 141-222)
Altrenogest oral solution ­(MATRIX)
Gilts (sexually mature gilts that have had at least one estrous cycle). For synchronization of estrus.

ORAL — The NADA provides for use of an altrenogest oral solution in gilts for synchronization of estrus.

Federal Register  10/31/03

Boehringer Ingelheim Vetmedica, Inc.
NADA 141-219
Meloxicam Injectable Solution (METACAM) Rx
Dogs. For the control of pain and inflammation associated with osteoarthritis.

INJECTABLE — The NADA provides for use of meloxicam injectable solution in dogs for the control of pain and inflammation associated with osteoarthritis.

Federal Register  12/10/03