• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Animal & Veterinary

  • Print
  • Share
  • E-mail

Supplemental New Animal Drug Approvals - July/August 2003

FDA Veterinarian Newsletter July/August 2003 Volume XVIII, No 4

Company
Generic and (Brand) Names
Indications
Routes/Remarks

Bayer Corp.
Agriculture Division, Animal Health
(141-007)
Praziquantel, Pyrantel Pamoate
Febantel (Drontal Plus)
Dogs. For the removal of several species of internal parasites.
ORAL—The supplement provides for the use of a larger size of tablet.
Federal Register 04/28/03

Intervet, Inc.
(NADA 128-620)
Fenbendazole (Safe-Guard®)
Goats. For removal and control of stomach worms.
ORAL—The supplement provides for a change to over-the-counter marketing status for the oral use of fenbendazole suspension in goats.
Federal Register 05/15/03

Lloyd, Inc.
(NADA 139-236)
Xylazine (Cervizine 300) RX
Elk and Wild Deer. To produce sedation.
INTRAMUSCULAR—The supplemental NADA provides for use of a 300 milligram per milliliter strength of xylazine hydrochloride solution in elk and wild deer to produce sedation, accompanied by a shorter period of analgesia. A revised food safety limitation and cautionary statement are added.
Federal Register 05/15/03

Intervet, Inc.
(NADA 141-034)
Bambermycins (Gainpro®)
Cattle. For increased rate of weight gain.
MEDICATED FEED—The supplemental NADA provides for use of bambermycins Type A medicated articles to make Type B and Type C medicated feeds used to increase rate of weight gain in pasture cattle (slaughter, stocker, feeder, and dairy and beef replacement heifers) when consumed free-choice or hand-fed at the rate of not less than 10 mg nor more than 40 mg bambermycins per head/day.
Federal Register 05/21/03

Intervet, Inc.
(NADA 131-675)
Fenbendazole (Safe-Guard® 20%)
Horses. For the control of gastrointestinal worms.
MEDICATED FEED—The supplemental NADA provides for use of SAFE –GUARD Type A medicated article to make Type B and Type C medicated horse feeds. The medicated feeds are used for the control of large strongyles, small strongyles, pinworms, and ascarids.
Federal Register 06/10/03

Pfizer, Inc.
(NADA 141-199)
Carprofen (Rimadyl®) RX
Dogs. For relief of pain and inflammation associated with osteoarthritis.
SUBCUTANEOUS—The supplemental NADA provides for a once daily, 2-mg/lb dosage of carprofen solution by subcutaneous injection.
Federal Register 06/11/03

Alpharma, Inc.
(NADA 96-298)
Lasalocid (Bovatec® 68)
Cattle. For increased rate of weight gain.
MEDICATED FEED—The supplemental NADA provides for the use of lasalocid Type A medicated article to make free-choice, loose mineral Type C medicated feeds used for increased rate of weight gain in pasture cattle (slaughter, stocker, feeder, and dairy and beef replacement heifers). The regulations are also being revised to provide current references for the amounts of selenium and ethylenediamine dihydroiodide (EDDI) permitted in other free-choice cattle feeds.
Federal Register 06/19/03