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Electronic Code of Federal Regulations

e-CFR Data is current as of April 23, 2014

Title 21: Food and Drugs
PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS


§520.1452   Moxidectin gel.

(a) Specifications. Each milliliter of gel contains 20 milligrams (2 percent) moxidectin.

(b) Sponsor. See No. 000856 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. 0.4 milligram moxidectin per kilogram (2.2 pounds) of 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; Cyliocostephanus 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); and horse stomach bots: Gasterophilus intestinalis (2nd and 3rd instars) and G. nasalis (3rd instars). One dose also suppresses strongyle egg production for 84 days.

(3) Limitations. For oral use in horses and ponies 6 months of age and older. Not for use in horses and ponies intended for food.

[62 FR 42902, Aug. 11, 1997, as amended at 64 FR 66105, Nov. 24, 1999; 68 FR 51445, Aug. 27, 2003; 69 FR 24959, May 5, 2004; 70 FR 75017, Dec. 19, 2005]



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