[Federal Register Volume 62, Number 124 (Friday, June 27, 1997)]
[Rules and Regulations]
[Pages 34631-34632]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-16791]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 510 and 520
Animal Drugs, Feeds, and Related Products; Selegiline
Hydrochloride Tablet
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 Deprenyl Animal Health, Inc. The NADA provides for oral
use of selegiline hydrochloride tablets for dogs for the control of
clinical signs associated with uncomplicated pituitary-dependent
hyperadrenocorticism.
EFFECTIVE DATE: June 27, 1997.
FOR FURTHER INFORMATION CONTACT: Marcia K. Larkins, Center For
Veterinary Medicine (HFV-112), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-594-0614.
SUPPLEMENTARY INFORMATION: Deprenyl Animal Health, Inc., 7101 College
Blvd., suite 580, Overland Park, KS 66210, filed NADA 141-080, which
provides for oral use of Anipryl (selegiline hydrochloride)
tablets for dogs for the control of clinical signs associated with
uncomplicated pituitary-dependent hyperadrenocorticism. The drug is
limited to use by or on the order of a licensed veterinarian. The NADA
is approved as of May 30, 1997, and the regulations are amended by
adding new 21 CFR 520.2098 to reflect the approval. The basis of
approval is discussed in the freedom of information summary.
In addition, Deprenyl Animal Health, Inc., has not previously been
listed in the animal drug regulations as the sponsor of an approved
application. At this time, 21 CFR 510.600(c) is amended to add listings
for the firm.
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. to 4 p.m., Monday to Friday.
Under section 512(c)(2)(F)(i) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(i)), this approval qualifies for
5 years of marketing exclusivity beginning May 30, 1997, because no
active ingredient of the drug, including any ester or salt of the
active ingredient, has been approved in any other application.
FDA has carefully considered the potential environmental effects of
this action and has concluded that this action will not have a
significant impact on the human environment, and that an environmental
impact statement is not required. FDA'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
(see above).
List of Subjects
21 CFR Part 510
Administrative practice and procedure, Animal drugs, Labeling,
Reporting and recordkeeping requirements.
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 parts 510 and
520 are amended as follows:
PART 510--NEW ANIMAL DRUGS
1. The authority citation for 21 CFR part 510 continues to read as
follows:
Authority: Secs. 201, 301, 501, 502, 503, 512, 701, 721 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321, 331, 351, 352,
353, 360b, 371, 379e).
2. Section 510.600 is amended in the table in paragraph (c)(1) by
alphabetically adding a new entry for ``Deprenyl Animal Health,
Inc.''and in the table in paragraph (c)(2) by numerically adding a new
entry for ``063248'' to read as follows:
Sec. 510.600 Names, addresses, and drug labeler codes of sponsors of
approved applications.
* * * * *
(c) * * *
(1) * * *
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Firm name and address Drug labeler code
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* * * * * *
*
Deprenyl Animal Health, Inc., 7101 College Blvd., suite 063248
580, Overland Park., KS 66210.
* * * * * *
*
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(2) * * *
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Drug labeler code Firm name and address
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* * * * * *
*
063248 Deprenyl Animal Health, Inc., 7101 College Blvd., suite
580, Overland Park, KS 66210.
* * * * * *
*
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[[Page 34632]]
PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS
3. The authority citation for 21 CFR part 520 continues to read as
follows:
Authority: Sec. 512 of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 360b).
4. New Sec. 520.2098 is added to read as follows:
Sec. 520.2098 Selegiline hydrochloride tablets.
(a) Specifications. Each tablet contains either 2, 5, 10, 15, or 30
milligrams of selegiline hydrochloride.
(b) Sponsor. See No. 063248 in Sec. 510.600(c) of this chapter.
(c) [Reserved]
(d) Conditions of use-- (1) Dosage. 1 milligram per kilogram (0.45
milligram per pound) of body weight.
(2) Indications for use. For control of clinical signs associated
with uncomplicated pituitary-dependent hyperadrenocorticism.
(3) Limitations. Administer orally once daily. If no improvement in
clinical signs or physical examination findings after 2 months of
therapy, increase dose to a maximum of 2 milligrams per kilogram once
daily. Federal law restricts this drug to use by or on the order of a
licensed veterinarian.
Dated: June 16, 1997.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 97-16791 Filed 6-26-97; 8:45 am]
BILLING CODE 4160-01-F
