Implantation or Injectable Dosage Form New Animal Drugs; Tolazoline Hydrochloride Injection

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a new animal drug application (NADA) filed by Lloyd, Inc. The NADA provides for intravenous use of tolazoline hydrochloride injection in horses when it is desirable to reverse the effects of sedation and analgesia caused by xylazine. EFFECTIVE DATE: May 23, 1996. FOR FURTHER INFORMATION CONTACT: Sandra K. Woods, Center for Veterinary Medicine (HFV-114), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-594-1616. SUPPLEMENTARY INFORMATION: Lloyd, Inc., 604 W. Thomas Ave., Shenandoah, IA 51601, filed NADA 140-994, which provides for intravenous use of Tolazine<SUP>TM Injection (each milliliter contains tolazoline hydrochloride equivalent to 100 milligrams of base activity) in horses when it is desirable to reverse the effects of sedation and analgesia caused by xylazine. The drug is limited to use on or by the order of a licensed veterinarian. The NADA is approved as of April 19, 1996, and the regulations are amended in part 522 (21 CFR part 522) by adding new Sec. 522.2474 to reflect the approval. The basis of approval is discussed in the freedom of information summary. In accordance with the freedom of information provisions of part 20 (21 CFR part 20) and Sec. 514.11(e)(2)(ii) (21 CFR 514.11(e)(2)(ii)), a summary of safety and effectiveness data and information submitted to support approval of this application may be seen in the Dockets Management Branch (HFA-305), Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857, between 9 a.m. and 4 p.m., Monday through Friday. -Under section 512(c)(2)(F)(i) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360b(c)(2)(F)(i)), this approval qualifies for a 5-year period of marketing exclusivity beginning April 19, 1996, because no active ingredient (including any ester or salt of the active ingredient) has been approved in any other application under section 512