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U.S. Department of Health and Human Services

Animal & Veterinary

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Approvals for March Through June 2005

FDA Veterinarian Newsletter May/June 2005 Volume XX, No III

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

  • SPECTRAMAST DC (ceftiofur hydrochloride) Sterile Suspension (NADA 141-239), filed by Pharmacia & Upjohn, a Division of Pfizer, Inc. The NADA provides for the veterinary prescription use of ceftiofur hydrochloride suspension, by intramammary infusion, for the treatment of subclinical mastitis in dairy cattle at the time of dry off associated with Staphylococcus aureus, Streptococcus dysgalactiae, and Streptococcus uberis. Notice of approval was published April 18, 2005.
  • CYDECTIN (moxidectin) Injectable Solution for Beef and Nonlactating Dairy Cattle (NADA 141-220), filed by Fort Dodge Animal Health. The NADA provides for use of an injectable moxidectin solution for the treatment and control of various internal and external parasites of cattle (i.e., gastrointestinal roundworms, lungworms, cattle grubs, mites, and lice). Notice of approval was published June 23, 2005.
  • TRIBUTAME Euthanasia Solution (embutramide; chloroquine phosphate, U.S.P.; and lidocaine, USP) (NADA 141 245), filed by Phoenix Scientific, Inc. The NADA provides for veterinary prescription use of the solution by intravenous injection for euthanasia of dogs. Notice of approval was published June 23, 2005.

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

  • COMBI-PEN-48 (Penicillin G Benzathine and Penicillin G Procaine Injectable Suspension) (NADA 065-506), filed by Cross Vetpharm Group Ltd. The supplemental NADA provides for a change in the proprietary name on the OTC label product from COMBICILLIN-AG to COMBI-PEN-48 and the addition of the statements “A withdrawal period has not been established for the product in pre-ruminating calves. Do not use in calves to be processed for veal.” to the warning section of the product labeling. Notice of approval was published April 28, 2005.
  • RALGRO (zeranol) (NADA 038-233), filed by Schering-Plough Animal Health Corp., a subcutaneous implant used in cattle and in sheep for improved feed efficiency and/or increased rate of weight gain. The supplemental NADA provides for the establishment of a tolerance for residues of zeranol in edible tissues of sheep. Accordingly, the analytical method for detecting residues of zeranol in uncooked edible tissues of sheep is being removed from the animal drug regulations 21 CFR Part 556. Notice of approval was published March 29, 2005.
  • Pyrantel Pamoate Paste (pyrantel pamoate) (NADA 200-342), filed by Phoenix Scientific, Inc. The supplemental provides for oral use for the removal and control of mature infections of tapeworms (Anoplocephala perfoliata) in horses and ponies. Notice of approval was published May 23, 2005.

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

  • Tiamulin Soluble Antibiotic (tiamulin hydrogen fumarate) (ANADA 200-344), filed by Phoenix Scientific, Inc. The supplemental ANADA provides for use of tiamulin soluble powder to prepare medicated drinking water for the treatment of swine dysentery and swine pneumonia. Phoenix Scientific, Inc.’s Tiamulin Soluble Antibiotic is approved as a generic copy of Boehringer Ingelheim Vetmedica, Inc.’s DENAGARD (tiamulin) Soluble Antibiotic approved under NADA 134-644. Notice of approval was published March 18, 2005.
  • Carprofen Caplets (ANADA 200-366), filed by IMPAX Laboratories, Inc. The ANADA provides for veterinary prescription use of Carprofen Caplets (carprofen) in dogs for the relief of pain and inflammation associated with osteoarthritis. IMPAX Laboratories, Inc.’s Carprofen Caplets is approved as a generic copy of Pfizer, Inc.’s RIMADYL Caplets, approved under NADA 141-053. Notice of approval was published May 27, 2005.