subchapter_subject: "ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS"
part_code: "520"
part_subject: "ORAL DOSAGE FORM NEW ANIMAL DRUGS"
subpart_code: "B"
subpart_subject: "Specific Administrative Rulings and Decisions"
section_number: "520.1453"
section_subject: "Moxidectin and praziquantel gel."
cfr_reference: "21 CFR 520.1453"
title_name: "Title 21"
title_subject: "Food and Drugs"
parts_covered: "Parts 500 to 599"
revised_date: "Revised as of April 1, 2019"
publication_date: "As of April 1, 2019"
contains_description: "Containing a codification of documents of general applicability and future effect"
publication_info: "Published by the Office of the Federal Register National Archives and Records Administration as a Special Edition of the Federal Register"
---
(a)Specifications. Each milliliter of gel contains 20 milligrams (mg) (2.0 percent) moxidectin and 125 mg (12.5 percent) praziquantel.
(b)Sponsor. See No. 054771 in § 510.600(c) of this chapter.
(c)Special considerations. See § 500.25 of this chapter.
(d)Conditions of use in horses and ponies—(1) Amount. Administer by mouth as a single dose: 0.4 mg moxidectin per kilogram and 2.5 mg praziquantel per kilogram (2.2 pounds) body weight.
(2)Indications for use. For the treatment and control of large strongyles:
Strongylus vulgaris (adults and L4/L5 arterial stages), S.
edentatus (adult and tissue stages), Triodontophorus brevicauda (adults), and T.
serratus (adults); small strongyles (adults): (Cyathostomum spp., including C. catinatum and C. pateratum; Cylicocyclus spp., including C. insigne, C. leptostomum, C. nassatus, and C. radiatus; Cylicostephanus spp., including C. calicatus, C. goldi, C. longibursatus, and C. minutus; Coronocyclus spp., including C. coronatus, C. labiatus, and C. labratus; Gyalocephalus capitatus; and Petrovinema poculatus; small strongyles: undifferentiated lumenal larvae; encysted cyathostomes (late L3 and L4 mucosal cyathostome larvae); ascarids: Parascaris equorum (adults and L4 larval stages); pinworms: Oxyuris equi (adults and L4 larval stages); hairworms: Trichostrongylus axei (adults); large-mouth stomach worms: Habronema muscae (adults); horse stomach bots: Gasterophilus intestinalis (2nd and 3rd instars) and G.
nasalis (3rd instars); and tapeworms: Anoplocephala perfoliata (adults). One dose also suppresses strongyle egg production for 84 days.
(3)Limitations. Do not use in horses intended for human consumption.