Animal & Veterinary
Drug Approvals – August to December, 2010
Editor’s Note: The following is by application type and in date order, with the most recent first. For the complete Federal Register notice, go to http://www.gpoaccess.gov/fr/advanced.html.
Original New Animal Drug Applications (NADAs)
EQUIDONE (domperidone) Gel (NADA 141-314), filed by Dechra, Ltd. The original NADA provides for prescription use of domperidone oral gel for prevention of fescue toxicosis in periparturient mares. Notice of approval published November 1, 2010.
EQUIOXX (firocoxib) Injection (NADA 141-313), filed by Merial Ltd. The original NADA provides for prescription use of firocoxib injectable solution in horses for the control of pain and inflammation associated with osteoarthritis. Notice of approval published September 28, 2010.
Supplemental New Animal Drug Applications (NADAs):
EXCEDE (ceftiofur crystalline free acid) for Swine Sterile Suspension (NADA 141-235), filed by Pharmacia & Upjohn, Co., a division of Pfizer, Inc. The supplemental NADA provides for prescription use of ceftiofur crystalline free acid suspension in swine, by intramuscular injection, for the control of swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Haemophilus parasuis, and Streptococcus suis in groups of pigs where SRD has been diagnosed. Notice of approval published October 12, 2010.
DEXDOMITOR (dexmedetomidine hydrochloride) (NADA 141-267), filed by Orion Corp. The supplemental NADA provides for prescription use of dexmedetomidine hydrochloride injectable solution as a pre-anesthetic to general anesthesia in cats. Notice of approval published September 30, 2010.
Original Abbreviated New Animal Drug Applications (ANADAs):
PHARMASIN (tylosin tartrate) Soluble, ANADA 200-473, filed by Huvepharma AD. The original ANADA provides for use of tylosin tartrate soluble powder in drinking water for chickens, turkeys, swine, and honey bees for the treatment or control of various bacterial diseases. Notice of approval published December 8, 2010.
Supplemental Abbreviated New Animal Drug Applications (ANADAs):
FLU-NIX (flunixin meglumine) Injectable Solution, ANADA 200-061, filed by Agri Laboratories, Ltd. The supplemental ANADA provides for use of flunixin meglumine solution by intravenous injection in lactating dairy cows for control of pyrexia associated with acute bovine mastitis. Notice of approval published December 8, 2010.