CFR

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 § 510.600(c) of this chapter.

(d) Conditions of use— (1) Horses— 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]

Code of Federal Regulations

[63 FR 44382, Aug. 19, 1998]

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