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U.S. Department of Health and Human Services

Animal & Veterinary

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Approvals for September–November 2008

CVM has published in the Federal Register notice of the approval of these.

Supplemental New Animal Drug Applications (NADA)

  • REBALANCE (sulfadiazine/pyrimethamine) Antiprotozoal Oral Suspension (supplement to NADA 141-240), filed by Animal Health Pharmaceuticals, LLC, St. Joseph, MO. The NADA is approved for the treatment of equine protozoal myeloencephalitis (EPM) caused by Sarcocystis neurona. The supplemental NADA provides for a revised human food safety warning on the labeling. Notice of approval was published September 17, 2008.
  • SAFE-GUARD (fenbendazole) 20% Type A medicated article (supplement to NADA 131-675), filed by Intervet Inc., Millsboro, DE. The supplemental NADA provides for manufacture of a fenbendazole free choice, liquid Type C medicated feed for use in dairy and beef cattle for the removal and control of various internal parasites. Notice of approval was published October 8, 2008.
  • EXCEDE (ceftiofur crystalline free acid) Sterile Suspension (supplement to NADA 141-209), filed by Pharmacia & Upjohn Co., a Division of Pfizer, Inc., New York, NY. The supplemental NADA provides for veterinarian prescription use of ceftiofur crystalline free acid injectable suspension for the treatment of bovine foot rot (interdigital necrobacillosis) in beef, non-lactating, and lactating dairy cattle. Notice of approval was published October 8, 2008.
  • DRAXXIN (tulathromycin) Injectable Solution (supplement to NADA 141-244), filed by Pfizer, Inc., New York, NY. The supplemental NADA provides for treatment of bovine foot rot (interdigital necrobacillosis) associated with Fusobacterium necrophorum and Porphyromonas levii in beef and non-lactating dairy cattle. Notice of approval was published October 8, 2008.
  • PREVICOX (firocoxib) Chewable Tablets (supplement to NADA 141-230), filed by Merial Ltd., Duluth, GA. The supplemental NADA provides for the veterinary prescription use of firocoxib chewable tablets in dogs for the control of postoperative pain and inflammation associated with orthopedic surgery. Notice of approval was published October 31, 2008.

CVM has published in the Federal Register notice of the approval of these.

Abbreviated New Animal Drug Applications (ANADA)

  • Phenylbutazone Tablets (ANADA 200-433), filed by First Priority, Inc., Elgin, IL. The ANADA provides for the veterinary prescription use of Phenylbutazone Tablets in horses for the relief of inflammatory conditions associated with the musculoskeletal system. The product is approved as a generic copy of First Priority, Inc.’s, PRIBUTAZONE Tablets, approved under NADA 048-647. Notice of approval was published November 12, 2008.