[Code of Federal Regulations]
[Title 21, Volume 6]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR522.84]

[Page 218]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS--Table of Contents
 
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]

[63 FR 44382, Aug. 19, 1998]