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U.S. Department of Health and Human Services

Animal & Veterinary

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Abbreviated New Animal Drug Approvals - July/August 2004

FDA Veterinarian Newsletter July/August 2004 Volume XIX, No IV

Company
Generic and (Brand) Names
Indications
Routes/Remarks

Pennfield Oil Company
(ANADA 200-359)
Chlortetracycline and decoquinate (Pennchlor and Deccox)
Calves, beef and nonlactating dairy cattle. For the prevention of coccidiosis caused by Eimeria bovis and E. zuernii; for treatment of bacterial enteritis caused by Escherichia coli; for bacterial pneumonia caused by Pasteurella multocida organisms susceptible to chlortetracycline.
MEDICATED FEED—The ANADA provides for the use of single-ingredient, chlortetracycline and decoquinate Type A medicated articles to make two-way combination drug Type B and Type C medicated feeds. Pennfield Oil Company’s Pennchlor and Deccox is approved as a generic copy of Alpharma, Inc.’s NADA 141-147.
Federal Register 05/13/04

Veterinary Laboratories, Inc.
(ANADA 200-341)
Ivermectin (Sparmectin-E)
Horses. For the treatment and control of various species of internal and cutaneous parasites.
ORAL—The ANADA provides for oral use of Sparmectin-E Liquid for horses for the treatment and control of various species of internal and cutaneous parasites. Veterinary Laboratories’ Sparmectin-E Liquid for Horses is approved as a generic copy of Merial Ltd.’s NADA 140-439.
Federal Register 05/05/04

Pennfield Oil Company
(ANADA 200-356)
Chlortetracycline hydrochloride and tiamulin hydrogen fumarate (Pennchlor and Denagard)
Swine. For the treatment of swine bacterial enteritis caused by Escherichia coli and Salmonella choleraesuis and bacterial pneumonia caused by Pasteurella multocida susceptible to chlortetracycline, and control of swine dysentery associated with Brachyspira (formerly Serpulina or Treponema) hyodysenteriae susceptible to tiamulin.
MEDICATED FEED—The ANADA provides for the use of single-ingredient Type A medicated articles containing tiamulin hydrogen fumarate and chlortetracycline hydrochloride to make two-way combination drug Type B and Type C medicated feeds for swine. Pennfield Oil Company’s Pennchlor and Denagard is approved as a generic copy of Boehringer Ingelheim Vetmedica, Inc.’s NADA 141-011.
Federal Register 06/08/04

Boehringer Ingelheim Vetmedica, Inc.
(ANADA 200-361)
Acepromazine maleate injection (Acepromazine Maleate Injection)
Dogs, cats, and horses. For use as a tranquilizer.
INJECTABLE—The ANADA provides for the veterinary prescription use of acepromazine maleate injectable solution in dogs, cats and horses as a tranquilizer. Boehringer Ingelheim Vetmedica’s Acepromazine Maleate Injection is approved as a generic copy of Fort Dodge Animal Health’s Promace Injectable approved under NADA 015-030.
Federal Register 06/17/04

Cross Vetpharm Group Ltd.
(ANADA 200-317)
Dexamethasone sodium phosphate (Dexium-SP Injectable Solution)
Horses. A rapid adrenal glucocorticoid and/or anti-inflammatory agent.
INJECTABLE—The ANADA provides for the veterinary prescription use of dexamethasone sodium phosphate injectable solution as a rapid adrenal glucocorticoid and/or anti-inflammatory agent in horses. Cross Vetpharm Group Ltd.’s Dexium-SP is approved as a generic copy of Steris Laboratories, Inc.’s Dexamethasone Injection, approved under NADA 104-606.
Federal Register 06/18/04

Phoenix Scientific, Inc.
(ANADA 200-193)
Clindamycin Hydrochloride Oral Liquid (Clindamycin Hydrochloride Oral Liquid)
Cats and dogs. For the treatment of certain bacterial diseases.
ORAL—The supplemental ANADA provides for an expanded dose range and revised indications for the use of clindamycin hydrochloride oral liquid in both dogs and cats for the treatment of certain bacterial diseases.
Federal Register 06/07/04

Phoenix Scientific, Inc.
(ANADA 200-298)
Clindamycin hydrochloride capsules (Clindamycin Hydrochloride Capsules)
Dogs. For the treatment of certain bacterial diseases.
ORAL—Two supplemental ANADAs were filed. One supplemental ANADA provides for an expanded dose range and revised indications wording for the oral use of clindamycin hydrochloride capsules in dogs for the treatment of certain bacterial diseases. The other supplemental ANADA provides for the use of a 300-milligram capsule size.
Federal Register 06/09/04