[Federal Register Volume 63, Number 149 (Tuesday, August 4, 1998)]
[Rules and Regulations]
[Page 41419]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-20699]



[[Page 41419]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 520


Oral Dosage Form New Animal Drugs; Clenbuterol

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 Boehringer Ingelheim Animal Health, Inc. The NADA 
provides for veterinary prescription use of clenbuterol syrup 
(clenbuterol hydrochloride) indicated for the management of horses 
affected with airway obstruction, such as occurs in chronic obstructive 
pulmonary disease (COPD).

EFFECTIVE DATE: August 4, 1998.

FOR FURTHER INFORMATION CONTACT: Linda M. Wilmot, Center for Veterinary 
Medicine (HFV-114), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 301-594-0614.

SUPPLEMENTARY INFORMATION: Boehringer Ingelheim Animal Health, Inc., 
2621 North Belt Highway, St. Joseph, MO 64506-2002, has filed NADA 140-
973 that provides for veterinary prescription use of 
VENTIPULMIN Syrup (clenbuterol hydrochloride) indicated for 
the management of horses affected with airway obstruction, such as 
occurs in COPD. The NADA is approved as of May 11, 1998, and the 
regulations are amended by adding 21 CFR 520.452 to reflect the 
approval. The basis for approval is discussed in the freedom of 
information summary.
    In accordance with the freedom of information provisions of 21 CFR 
part 20 and 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 5 years of marketing exclusivity beginning May 11, 1998, 
because no active ingredient of the drug, including any ester or salt 
of the active ingredient, has been previously approved in any other 
application filed under section 512(b)(1) of the act.
    The agency has determined under 21 CFR 25.33(d)(1) that this action 
is of a type that does not individually or cumulatively have a 
significant effect on the human environment. Therefore, neither an 
environmental assessment nor an environmental impact statement is 
required.

List of Subjects in 21 CFR Part 520

    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 520 is 
amended as follows:

PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS

    1. The authority citation for 21 CFR part 520 continues to read as 
follows:

    Authority: 21 U.S.C. 360b.

    2. Section 520.452 is added to read as follows:


Sec. 520.452  Clenbuterol syrup.

    (a) Specifications. Each milliliter contains 72.5 micrograms of 
clenbuterol hydrochloride.
    (b) Sponsor. See 000010 in Sec. 510.600(c) of this chapter.
    (c) [Reserved]
    (d) Conditions of use--(1) Horses--(i) Amount. Administer orally 
twice a day (b.i.d.). Initial dose is 0.5 milliliter per 100 pounds 
body weight (0.8 micrograms per kilogram) for 3 days (6 treatments). If 
no improvement, administer 1 milliliter per 100 pounds (1.6 micrograms 
per kilogram) for 3 days (6 treatments). If no improvement, administer 
1.5 milliliters per 100 pounds (2.4 micrograms per kilogram) for 3 days 
(6 treatments). If no improvement, administer 2.0 milliliters per 100 
pounds (3.2 micrograms per kilogram) for 3 days (6 treatments). If no 
improvement, horse is nonresponder to clenbuterol and treatment should 
be discontinued.
    (ii) Indications for use. Indicated for the management of horses 
affected with airway obstruction, such as occurs in chronic obstructive 
pulmonary disease (COPD).
    (iii) Limitations. Treat at effective dose for 30 days. At the end 
of the 30-day treatment period, drug should be withdrawn. If signs 
return, the 30-day treatment period may be repeated. If repeating 
treatment, the step-wise dosage schedule should be repeated. The effect 
of this drug on breeding stallions and brood mares has not been 
determined. Treatment starting with dosages higher than the initial 
dose is not recommended. Federal law prohibits the extralabel use of 
this drug in food animals. Federal law restricts this drug to use by or 
on the order of a licensed veterinarian.
    (2) [Reserved]

    Dated: June 30, 1998.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 98-20699 Filed 8-3-98; 8:45 am]
BILLING CODE 4160-01-F