[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
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* * * * * *
*
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
