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U.S. Department of Health and Human Services

Animal & Veterinary

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Approvals for November and December 2004

FDA Veterinarian Newsletter January/February 2005 Volume XX, No I

CVM has published in the Federal Register notice the approval of these New Animal Drug Approvals (NADAs)

REBALANCE Antiprotozoal Oral Suspension (sulfadiazine/pyrimethamine) filed by Animal Health Pharmaceuticals, LLC. (NADA 141-240). The NADA provides for veterinary prescription use of an oral suspension of sulfadiazine and pyrimethamine for the treatment of equine protozoal myeloencephalitis (EPM) caused by Sarcocystis neurona. Notice of approval was published December 2, 2004.

CVM has published in the Federal Register notice the approval of these Supplemental New Animal Drug Approvals (NADAs)

PULMOTIL 90 (tilmicosin phosphate) Type A medicated article filed by Elanco Animal Health (NADA 141-064). The supplemental NADA provides for the use of the product in swine feed for the control of swine respiratory disease associated with certain bacterial organisms. The supplemental NADA provides for revised reproductive safety labeling. Notice of approval was published December 30, 2004.

FINAPLIX-H (trenbolone acetate) filed by Intervet, Inc. (NADA 138-612). The supplemental NADA provides for the addition of statements to labeling warning against the use of the product in calves to be processed for veal. Notice of approval was published December 2, 2004.

SYNOVEX C and SYNOVEX S (progesterone and estradiol benzoate) filed by Fort Dodge Animal Health, Division of Wyeth (NADA 009-576). The supplemental NADA provides for the addition of statements to labeling warning against the use of these products in calves to be processed for veal. Notice of approval was published in December 2, 2004.

COMPONENT E-C and COMPONENT E-S (progesterone and estradiol benzoate), and COMPONENT E-C with TYLAN and COMPONENT E-S with TYLAN (progesterone and estradiol benzoate with tylosin tartrate) filed by Ivy Laboratories, Division of Ivy Animal Health, Inc. (NADA 110-315). The supplemental NADA provides for the addition of statements to the labeling warning against the use of these products in calves to be processed for veal. Notice of approval was published December 2, 2004.

METACAM (meloxicam) Solution for Injection filed by Boehringer Ingelheim Vetmedica, Inc. (NADA 141-219). The supplement provides for use of the product in cats for control of postoperative pain and inflammation associated with orthopedic surgery, ovariohysterectomy, and castration when administered prior to surgery, and also revises dosage information for use of this product in dogs. Notice of approval was published November 30, 2004.

METACAM (meloxicam) Oral Suspension filed by Boehringer Ingelheim Vetmedica, Inc. (NADA 141-213). The supplemental NADA provides revised dosage information for use of the product dogs. Notice of approval was published November 30, 2004.

RUMENSIN 80 (monensin sodium) Type A medicated article to formulate Type B and Type C medicated feeds filed by Elanco Animal Health, Division of Eli Lilly & Co. (NADA 095-735). The supplemental NADA provides for use of monensin Type A -medicated -articles to formulate Type B and Type C medicated feeds used for increased milk production efficiency (production of marketable solids-corrected milk per unit of feed intake) in dairy cows. Notice of approval was published November 26, 2004.

REVALOR (trenbolone acetate and estradiol) implants filed by Intervet, Inc. (NADAs 140-897 and 140-992). The supplemental NADAs provide for the addition of statements to labeling of subcutaneous implants containing trenbolone acetate and estradiol warning against the use of the products in calves to be processed for veal. Notice of approval was published November 24, 2004.

SYNOVEX H (estradiol benzoate and testosterone propionate) filed by Fort Dodge Animal Health, Division of Wyeth (NADA 011-427). The supplemental NADA provides for the addition of statements to labeling of subcutaneous implants containing estradiol benzoate and testosterone propionate warning against the use of these products in calves to be processed for veal. Notice of approval was published November 24, 2004.

COMPONENT E-H (estradiol benzoate and testosterone propionate) and COMPONENT E-H with TYLAN (estradiol benzoate and testosterone propionate with tylosin tartrate) filed by Ivy Laboratories, Division of Ivy Animal Health (NADA 135-906). The supplemental NADAs provide for the addition of statements to labeling of subcutaneous implants containing estradiol benzoate and testosterone propionate warning against the use of these products in calves to be processed for veal. Notice of approval was published November 24, 2004.

ENCORE (estradiol) and COMPUDOSE (estradiol) filed by Ivy Laboratories, Division of Ivy Animal Health, Inc. (NADA 118-123). The supplemental NADA provides for the addition of statements to labeling of subcutaneous implants containing estradiol warning against the use of these products in calves to be processed for veal. Notice of approval was published November 22, 2004.

SYNOVEX PLUS (trenbolone acetate and estradiol benzoate) and SYNOVEX CHOICE (trenbolone acetate and estradiol benzoate) filed by Fort Dodge Animal Health, Division of Wyeth (NADA 141-043). These two subcutaneous implants products are used in steers and heifers fed in confinement for slaughter for increased rate of weight gain and/or improved feed efficiency. The supplemental NADA provides for the addition of statements to labeling of subcutaneous implants containing trenbolone acetate and estradiol benzoate warning against the use of these products in calves to be processed for veal. Notice of approval was published November 22, 2004.

CVM has published in the Federal Register notice the approval of these Abbreviated New Animal Drug Approvals (ANADAs)

Furosemide Syrup 1% (furosemide) filed by Phoenix Scientific, Inc. (ANADA 200-382). The ANADA provides for veterinary prescription use of furosemide syrup in dogs by oral administration for treatment of edema associated with cardiac insufficiency and acute noninflammatory tissue edema. Phoenix Scientific’s Furosemide Syrup 1% is approved as a generic copy of Intervet, Inc.’s LASIX (furosemide) Syrup 1%, approved under NADA 102-380. Notice of approval was published December 14, 2004.

CVM has published in the Federal Register notice the approval of these Supplemental Abbreviated New Animal Drug Approvals (ANADAs)

COMPONENT T-H and COMPONENT T-S (trenbolone acetate), COMPONENT T-H with TYLAN and COMPONENT T-S with TYLAN (trenbolone acetate with tylosin tartrate) filed by Ivy Laboratories (ANADA 200-224). The supplemental ANADA provides for the addition of statements to the labeling warning against the use of these products in calves to be processed for veal. Notice of approval was published December 2, 2004.

COMPONENT (trenbolone acetate and estradiol) implants and COMPONENT plus TYLAN (trenbolone acetate and estradiol with tylosin tartrate) implants filed by Ivy Laboratories, Division of Ivy Animal Health (ANADAs 200-221 and 200-346). The supplemental ANADAs provide for the addition of statements to labeling of subcutaneous implants containing trenbolone acetate and estradiol warning against the use of the products in calves to be processed for veal. Notice of approval was published November 24, 2004.

SYNOVEX (trenbolone acetate and estradiol) implants filed by Fort Dodge Animal Health, Division of Wyeth (ANADA 200-367). The supplemental ANADA provides for the addition of statements to labeling of subcutaneous implants containing trenbolone acetate and estradiol warning against the use of the products in calves to be processed for veal. Notice of approval was published November 24, 2004.