[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
