[Federal Register Volume 63, Number 160 (Wednesday, August 19, 1998)]
[Rules and Regulations]
[Pages 44381-44382]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-22228]



[[Page 44381]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510 and 522


Implantation or Injectable Dosage Form New Animal Drugs; Beta-
Aminopropionitrile Fumarate

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 Alaco, Inc. The NADA provides for veterinary 
prescription use of beta-aminopropionitrile fumarate by injection for 
intratendinous treatment of superficial digital flexor tendinitis of 
horses.

EFFECTIVE DATE: August 19, 1998.

FOR FURTHER INFORMATION CONTACT: Melanie R. Berson, Center for 
Veterinary Medicine (HFV-110), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-594-0618.

SUPPLEMENTARY INFORMATION: Alaco, Inc., 1500 North Wilmot Rd., suite 
290-C, Tucson, AZ 85712, is the sponsor of NADA 141-107 that provides 
for the use of Bapten (beta-aminopropionitrile fumarate), a 
sterile lyophilized powder, after reconstitution with sterile 
physiologic saline, for the treatment of tendinitis of the superficial 
digital flexor tendon (SDFT) in the adult horse where there is 
sonographic evidence of fiber tearing. The drug is limited to use by or 
on the order of a licensed veterinarian. The NADA is approved as of 
June 10, 1998, and the regulations are amended by adding Sec. 522.84 to 
reflect the approval. The basis of approval is discussed in the freedom 
of information summary.
    In addition, Alaco, Inc., has not been previously listed in the 
animal drug regulations as sponsor of an approved application. At this 
time, 21 CFR 510.600(c) is amended to add entries 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, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, 
between 9 a.m. to 4 p.m., Monday through Friday.
    Under section 512(c)(2)(F)(i) of the Federal Food, Drug, and 
Cosmetic Act, this approval for nonfood-producing animals qualifies for 
5 years of marketing exclusivity beginning June 10, 1998, because no 
active ingredient of the drug (including any salt or ester of the 
active ingredient) has been approved in any other application.
    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

21 CFR Part 510

    Administrative practice and procedure, Animal drugs, Labeling, 
Reporting and recordkeeping requirements.

21 CFR Part 522

    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 
522 are amended as follows:

PART 510--NEW ANIMAL DRUGS

    1. The authority citation for 21 CFR part 510 continues to read as 
follows:

    Authority: 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 an entry for ``Alaco, Inc.'' and in the table in 
paragraph (c)(2) by numerically adding an entry for ``064146'' 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                    
----------------------------------------------------------------------------------------------------------------
  *                    *                    *                    *                    *                    *    
                                                             *                                                  
Alaco, Inc., 1500 North Wilmot Rd., suite 290-C,                                                                
 Tucson, AZ 85712.                                                                                       064146 
  *                    *                    *                    *                    *                    *    
                                                             *                                                  
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    (2) * * *

                                                                                                                
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                    Drug labeler code                                      Firm name and address                
----------------------------------------------------------------------------------------------------------------
  *                    *                    *                    *                    *                    *    
                                                             *                                                  
064146...................................................  Alaco, Inc., 1500 North Wilmot Rd., suite 290-C,     
                                                            Tucson, AZ 85712.                                   
  *                    *                    *                    *                    *                    *    
                                                             *                                                  
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[[Page 44382]]

PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

    1. The authority citation for 21 CFR part 522 continues to read as 
follows:

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

    2. Section 522.84 is added to read as follows:

Sec. 522.84  Beta-aminopropionitrile fumarate.

    (a) Specifications. Each vial contains 7.0 milligrams of beta-
aminopropionitrile fumarate sterile lyophilized powder which is 
reconstituted for injection with 10 milliliters of sterile physiologic 
saline, USP.
    (b) Sponsor. See No. 064146 in Sec. 510.600(c) of this chapter.
    (c) [Reserved]
    (d) Conditions of use--(1) Horses--(i) Amount. 7 milligrams (10 
milliliters) intralesionally every other day for 5 treatments beginning 
about 30 days after initial injury.
    (ii) Indications for use. For treatment of tendinitis of the 
superficial digital flexor tendon (SDFT) in the adult horse where there 
is sonographic evidence of fiber tearing.
    (iii) Limitations. Single dose container for intralesional 
injection. Do not use in horses with dermal irritation or open skin 
lesions in the injection area. Do not administer intraarticularly, into 
the tendon sheath, or in the presence of concurrent limb fractures. Do 
not use in breeding animals since the effects on fertility, pregnancy, 
or fetal health have not been determined. Not for use in horses 
intended for food. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.
    (2) [Reserved]

    Dated: July 29, 1998.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 98-22228 Filed 8-18-98; 8:45 am]
BILLING CODE 4160-01-F