[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                   
----------------------------------------------------------------------------------------------------------------
  *                    *                    *                    *                    *                    *    
                                                             *                                                  
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                 
----------------------------------------------------------------------------------------------------------------
  *                    *                    *                    *                    *                    *    
                                                             *                                                  
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