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Title 21: Food and Drugs
« Home / Title 21 - Food and Drugs--Volume 6 / CHAPTER I - FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) / SUBCHAPTER E - ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS / PART 520 - ORAL DOSAGE FORM NEW ANIMAL DRUGS / § 520.2645 Tylvalosin.
§ 520.2645 Tylvalosin.

(a) Specifications. Granules containing 62.5 percent tylvalosin (w/w) as tylvalosin tartrate.

(b) Sponsor. See No. 066916 in § 510.600(c) of this chapter.

(c) Related tolerances. See § 556.748 of this chapter.

(d) Conditions of use in swine - (1) Amount. Administer 50 parts per million (ppm) tylvalosin continuously in drinking water for 5 consecutive days.

(2) Indications for use. For control of porcine proliferative enteropathy (PPE) associated with Lawsonia intracellularis infection in groups of swine in buildings experiencing an outbreak of PPE; and for control of swine respiratory disease (SRD) associated with Bordetella bronchiseptica, Haemophilus parasuis, Pasteurella multocida, and Streptococcus suis in groups of swine in buildings experiencing an outbreak of SRD.

(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[77 FR 55415, Sept. 10, 2012, as amended at 83 FR 13635, Mar. 30, 2018]
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