21 CFR 520.2215 - Sulfadiazine/pyrimethamine suspension.

Regulations last checked for updates: Nov 22, 2024

Title 21 - Food and Drugs last revised: Nov 19, 2024

View all text of Part 520 [§ 520.23 - § 520.2654]

§ 520.2215 - Sulfadiazine/pyrimethamine suspension.

(a) Specifications. Each milliliter (mL) of suspension contains 250 milligrams (mg) sulfadiazine (as the sodium salt) and 12.5 mg pyrimethamine.

(b) Sponsor. See No. 055246 in § 510.600(c) of this chapter.

(c) Conditions of use in horses—(1) Amount. Administer orally 20 mg sulfadiazine per kilogram (kg) body weight and 1 mg/kg pyrimethamine daily.

(2) Indications for use. For the treatment of equine protozoal myeloencephalitis (EPM) 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.

[69 FR 70054, Dec. 2, 2004, as amended at 73 FR 53686, Sept. 17, 2008; 75 FR 69586, Nov. 15, 2010]

authority: 21 U.S.C. 360b.

source: 40 FR 13838, Mar. 27, 1975, unless otherwise noted.

cite as: 21 CFR 520.2215