Betamethasone sodium phosphate and betamethasone acetate.

  1. Law
  2. CFR 21
  3. Food and Drugs
  4. Food and Drug Administration, Department of Health and Human Services
  5. Animal Drugs, Feeds, and Related Products
  6. Implantation or Injectable Dosage Form New Animal Drugs
  7. Betamethasone sodium phosphate and betamethasone acetate.

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§ 522.167 Betamethasone sodium phosphate and betamethasone acetate.

(a) Specifications. Each milliliter (mL) of suspension contains 6 milligrams (mg) betamethasone (3.15 mg betamethasone sodium phosphate and 2.85 mg betamethasone acetate).

(b) Sponsor. See No. 010797 in § 510.600(c) of this chapter.

(c) Conditions of use in horses -

(1) Amount. Administer 1.5 mL (9 mg total betamethasone) per joint by intra-articular injection. May be administered concurrently in up to two joints per horse.

(2) Indications for use. For the control of pain and inflammation associated with osteoarthritis in horses.

(3) Limitations. Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[80 FR 18776, Apr. 8, 2015]


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