CFR - Code of Federal Regulations Title 21

The information on this page is current as of Dec 22, 2023.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

[Code of Federal Regulations]

[Title 21, Volume 6]

[CITE: 21CFR520.1855]

TITLE 21--FOOD AND DRUGS

CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES

SUBCHAPTER E - ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS

PART 520 -- ORAL DOSAGE FORM NEW ANIMAL DRUGS

Sec. 520.1855 Ponazuril.

(a) Specifications. Each gram of paste contains 150 milligrams (mg) ponazuril.

(b) Sponsor. See No. 000010 in § 510.600(c) of this chapter.

(c) Conditions of use in horses - (1) Amount. Administer orally 15 mg per kilogram (kg) (6.81 mg per pound (lb)) body weight as the first dose, followed by 5 mg/kg (2.27 mg/lb) body weight once daily for a period of 27 additional days.

(2) Indications for use. For the treatment of equine protozoal myeloencephalitis caused by Sarcocystis neurona.

(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.

[66 FR 43774, Aug. 21, 2001, as amended at 79 FR 28827, May 20, 2014; 80 FR 34278, June 16, 2015; 80 FR 53459, Sept. 4, 2015; 84 FR 39183, Aug. 9, 2019]