[Federal Register Volume 61, Number 101 (Thursday, May 23, 1996)]
[Rules and Regulations]
[Pages 25784-25785]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-12876]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 522


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

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Final rule.

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SUMMARY: 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(b)(1) of the act.
    The agency has carefully considered the potential environmental 
effects of this action. FDA has concluded that the action will not have 
a significant impact on the human environment, and that an 
environmental impact statement is not required. The agency's finding of 
no significant impact and the evidence supporting that finding, 
contained in an environmental assessment, may be seen in the Dockets 
Management Branch (address above) between 9 a.m. and 4 p.m., Monday 
through Friday.

[[Page 25785]]

List of Subjects 21 CFR Part 522

    -Animal drugs.
    -Therefore, under the Federal Food, Drug, and Cosmetic Act and 
under authority delegated to the Commissioner of Food and Drugs and 
redelegated to the Center for Veterinary Medicine, 21 CFR part 522 is 
amended as follows:

PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

    -1. The authority citation for 21 CFR part 522 continues to read as 
follows:

    -Authority: Sec. 512 of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 360b).

    -2. New Sec. 522.2474 is added to read as follows:

Sec. 522.2474   Tolazoline hydrochloride injection.

    -(a) Specifications. Each milliliter of sterile aqueous solution 
contains tolazoline hydrochloride equivalent to 100 milligrams of base 
activity.
    -(b) Sponsor. See No. 061690 in Sec. 510.600(c) of this chapter.
    -(c) Conditions of use.  It is used as follows:
    -(1) Horses--(i) Amount. Administer slowly by intravenous injection 
4 milligrams per kilogram of body weight or 1.8 milligrams per pound (4 
milliliters per 100 kilograms or 4 milliliters per 220 pounds).
    -(ii) Indications for use.  For use in horses when it is desirable 
to reverse the effects of sedation and analgesia caused by xylazine.
    -(iii) Limitations.  The safety of Tolazine<SUP>TM has not been 
established in pregnant mares, lactating mares, horses intended for 
breeding, foals, or horses with metabolically unstable conditions. The 
safety of Tolazine<SUP>TM has not been evaluated for reversing xylazine 
used as a preanesthetic to a general anesthetic. This drug is for use 
in horses only and not for use in food-producing animals. Users with 
cardiovascular disease (for example, hypertension or ischemic heart 
disease) should take special precautions to avoid accidental exposure 
to this product.
Accidental spillage on the skin should be washed off immediately with 
soap and water. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.
    -(2) [Reserved]

    Dated: May 15, 1996.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 96-12876 Filed 5-22-96; 8:45 am]
BILLING CODE 4160-01-F