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U.S. Department of Health and Human Services

Animal & Veterinary

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Approvals for January and February 2005

FDA Veterinarian Newsletter March/April 2005 Volume XX, No II

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

SPECTRAMAST LC (ceftiofur hydrochloride) Sterile Suspension filed by Pharmacia & Upjohn Co. (NADA 141-238). The NADA provides for the veterinary prescription use of ceftiofur hydrochloride suspension, by intramammary infusion, for the treatment of clinical mastitis in lactating dairy cattle associated with coagulase-negative staphylococci, Streptococcus dysgalactiae, and Escherichia coli. Notice of approval was published February 28, 2005.

ZIMECTERIN-EZ (ivermectin) 0.6% w/w for Horses filed by Merial, Ltd. (NADA 141-241). The application provides for use of ivermectin meal for the control of roundworms, lungworms, and bots in horses. Notice of approval was published January 11, 2005.

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

RALGRO (zeranol) filed by Schering-Plough Animal Health Corp. (NADA 038-233), a subcutaneous implant/product used in certain classes of cattle or sheep for improved feed efficiency and/or increased rate of weight gain. 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 February 9, 2005.

RALGRO LA (zeranol) filed by Schering-Plough Animal Health Corp. (NADA 141-192), a subcutaneous implant/product used in certain classes of cattle for increased rate of weight gain. 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 February 9, 2005.

DECCOX (decoquinate) Type A medicated article filed by Alpharma Inc. (NADA 141-147). The supplemental NADA provides for the use of single-ingredient decoquinate Type A medicated article to make two-way Type B and Type C medicated feeds for cattle at a broader range of concentrations. Notice of approval was published January 14, 2005.

AUREOMYCIN (chlortetracycline) Type A medicated article filed by Alpharma Inc. (NADA 141-185). The supplemental NADA provides for the use of single-ingredient chlortetracycline Type A medicated article to make two-way Type B and Type C medicated feeds for cattle at a broader range of concentrations. Notice of approval was published January 14, 2005.

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

EUTHANASIA III (pentobarbital sodium and phenytoin sodium) Solution filed by Med-Pharmex, Inc. (ANADA 200-280). The ANADA provides for the use of the product for the humane, painless, and rapid euthanasia of dogs. Med-Pharmex, Inc.’s EUTHANASIA-III Solution is approved as a generic copy of Schering-Plough Animal Health Corp.’s BEUTHANASIA-D Special, approved under NADA 119-807. Notice of approval was published February 24, 2005.

BIMECTIN (ivermectin) Paste 1.87% filed by Cross Vetpharm Group Ltd. (ANADA 200-326). The ANADA provides for oral use of 1.87% ivermectin paste in horses for the treatment and control of various species of internal parasites or parasitic conditions. Cross Vetpharm Group’s BIMECTIN Paste 1.87% is approved as a generic copy of -Merial Limited’s EQVALAN Paste, approved under NADA 134-314. Notice of approval was published February 22, 2005.

Levamisole Hydrochloride Soluble Drench Powder filed by Phoenix Scientific, Inc. (ANADA 200-386). The ANADA provides for the product to be used to make a drench solution for oral administration to cattle and sheep that is effective against various internal parasites. Phoenix Scientific’s Levamisole Hydrochloride Soluble Drench Powder is approved as a generic copy of Schering-Plough Animal Health Corp.’s, LEVASOL (levamisole hydrochloride) Soluble Drench Powder, approved under NADA 112-051. Notice of approval was published January 13, 2005.

LINCOMED (lincomycin hydrochloride) Soluble Powder filed by Cross Vetpharm Group Ltd. (ANADA 200-377). The ANADA provides for oral use of lincomycin soluble powder to make medicated drinking water for administration to swine for the treatment of swine dysentery or to broiler chickens for the control of necrotic enteritis. Cross Vetpharm Group Ltd.’s LINCOMED Soluble Powder is approved as a generic copy of Pharmacia & Upjohn Co.’s LINCOMIX Soluble Powder, approved under NADA 111-636. Notice of approval was published January 11, 2005.

HEIFERMAX 500 (melengestrol acetate) Liquid Premix filed by Ivy Laboratories (ANADA 200-343). The ANADA provides for use of a liquid Type A medicated article to make dry and liquid Type C medicated feeds for heifers fed in confinement for slaughter and for heifers intended for breeding. Ivy Laboratories’ HEIFERMAX 500 Liquid Premix is approved as a generic copy of Pharmacia and Upjohn Co.’s MGA 500 (melengestrol acetate) Liquid Premix, approved under NADA 39-402. Notice of approval was published January 14, 2005.

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

COMPONENT TE-200 (trenbolone acetate and estradiol) filed by Ivy Laboratories (ANADA 200-346). The supplemental ANADA provides for the addition of heifers to the label of COMPONENT TE-200 (trenbolone acetate and estradiol), a subcutaneous implant, containing 200 milligrams (mg) trenbolone acetate and 20 mg estradiol. The indications are for increased rate of weight gain and improved feed efficiency in steers and heifers fed in confinement for slaughter. Ivy Laboratories’ COMPONENT TE-200 is approved as a generic copy of Intervet, Inc.’s REVALOR-200, approved under NADA 140-992. Notice of approval was published February 18, 2005.

TRIPLEMAX (gentamicin sulfate, U.S.P.; betamethasone valerate, U.S.P.; and clotrimazole, U.S.P. ointment) filed by Phoenix Scientific, Inc. (ANADA 200-287) for the treatment of acute and chronic canine otitis externa. The supplement provides for a new container size, a 20-gram dropper bottle. Notice of approval was published February 18, 2005.