Animal & Veterinary
Approvals for June – August 2008
FDA Veterinarian Newsletter May / June 2008 Volume XXIII, No III
CVM has published in the Federal Register notice of the approval of these New Animal Drug Applications (NADA)
- EXCENEL RTU EZ (ceftiofur hydrochloride) Sterile Suspension (NADA 141-288), filed by Pharmacia & Upjohn Co., a Division of Pfizer, Inc., New York, NY. The approved NADA provides for the veterinary prescription use of EXCENEL RTU EZ (ceftiofur hy-drochloride) Sterile Suspension for the treatment of various bacterial infections in swine and cattle. Notice of approval was published August 6, 2008.
CVM has published in the Federal Register notice of the approval of these Supplemental New Animal Drug Applications (NADA)
- TERRAMYCIN 200 for Fish (oxytetracycline dihydrate) Type A medicated article (supplement to NADA 38-439), filed by Phibro Animal Health, Ridgefield Park, NJ. The NADA pro-vides for the use of TERRAMYCIN 200 for Fish Type A medicated article for the con-trol of certain bacterial diseases in several species of fish and for skeletal marking of Pacific salmon. The supplement provides for use of oxytetracycline dihydrate in Type C medicated feeds for the control of mortality in freshwater-reared salmonids due to coldwater disease associated with Flavobacterium psychrophilum and for the control of mortality in freshwater-reared Oncorhynchus mykiss due to columnaris disease as-sociated with Flavobacterium columnare. Notice of approval was published August 7, 2008.
- COCCIPROL (amprolium) 9.6% Oral Solution (supplement to NADA 13-633), filed by Phibro Animal Health, Ridgefield Park, NJ. The NADA provides for the use of COCCIPROL 9.6% Oral Solution to make medicated drinking water for chickens and turkeys for the treatment of coccidiosis; the approved supplemental NADA provides for label revi-sions associated with a previous change of sponsoring and other minor changes. No-tice of approval was published August 6, 2008.
- SYNANTHIC (oxfendazole) Bovine Dewormer Suspension (supplement to NADA 140-854), filed by Fort Dodge Animal Health, Division of Wyeth, Fort Dodge, IA. The NADA pro-vides for the oral use of SYNANTHIC Bovine Dewormer Suspension in cattle for the removal of various internal parasites; the supplemental NADA provides for a revised warning statement, label formatting changes, and revised scientific nomenclature for parasite species. Notice of approval was published August 6, 2008.
- VETISULID (sulfachloropyridazine sodium) Powder (NADA 33-373), filed by Fort Dodge Ani-mal Health, a Division of Wyeth Holdings Corp., Fort Dodge, IA. The NADA is ap-proved for the oral use of VETISULID Powder in calves and swine for the treatment of diarrhea caused or complicated by Escherichia coli (colibacillosis). The supplemental NADA provides for a revised warning statements and label formatting changes for oral use of sulfachloropyridazine in the milk replacer of ruminating calves. Notice of approval was published June 24, 2008.