[Federal Register Volume 64, Number 8 (Wednesday, January 13, 1999)]
[Rules and Regulations]
[Pages 2121-2122]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-739]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 520


Oral Dosage Form New Animal Drugs; Selegiline Hydrochloride 
Tablets

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 supplemental new animal drug 
application (NADA) filed by Pfizer, Inc. The supplemental NADA provides 
for oral veterinary prescription use of selegiline hydrochloride 
tablets for dogs for the control of clinical signs associated with 
cognitive dysfunction syndrome.

EFFECTIVE DATE: January 13, 1999.
FOR FURTHER INFORMATION CONTACT:  Melanie R. Berson, Center For 
Veterinary Medicine (HFV-110), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-7543.

SUPPLEMENTARY INFORMATION:  Pfizer, Inc., 235 East 42d St., New York, 
NY 10017, filed supplemental NADA 141-080 that provides for oral 
veterinary prescription use of Anipryl (selegiline 
hydrochloride) tablets for dogs for the control of clinical signs 
associated with canine cognitive dysfunction syndrome. The product is 
approved for the control of clinical signs associated with 
uncomplicated pituitary-dependent hyperadrenocorticism. The supplement 
is approved as of December 10, 1998, and the regulations are amended by 
revising 21 CFR 520.2098 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 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 supplemental 
application may be seen in the Dockets Management Branch (HFA-305), 
Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, 
MD 20852, between 9 a.m. and 4 p.m., Monday

[[Page 2122]]

through Friday, except on Federal holidays.
    Under 21 U.S.C. 360b(c)(2)(F)(iii), this approval for nonfood-
producing animals qualifies for 3 years of marketing exclusivity 
beginning December 10, 1998, because the supplement contains 
substantial evidence of the effectiveness of the drug involved or any 
studies of animal safety required for approval of the supplement and 
conducted or sponsored by the applicant. The 3 years of marketing 
exclusivity applies only to veterinary prescription use of the drug in 
dogs for the control of clinical signs associated with cognitive 
dysfunction syndrome.
    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 520.2098 is amended by redesignating paragraphs (d)(2) 
and (d)(3) as paragraphs (d)(1)(i) and (d)(1)(ii), respectively, and by 
adding paragraph (d)(2) to read as follows:


Sec. 520.2098   Selegiline hydrochloride tablets.

* * * * *
    (d) Conditions of use. * * *
    (2) Dosage. 0.5 to 1.0 milligram per kilogram of body weight once 
daily.
    (i) Indications for use. For the control of clinical signs 
associated with canine cognitive dysfunction syndrome.
    (ii) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.

    Dated: January 6, 1999.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 99-739 Filed 1-12-99; 8:45 am]
BILLING CODE 4160-01-F