Code of Federal Regulations (Last Updated: May 6, 2024) |
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 |
§ 520.1441 - Milbemycin.
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§ 520.1441 Milbemycin oxime.
(a) Specifications -
(1) Dogs. Each flavored tablet contains 2.3, 5.75, 11.5, or 23.0 milligrams
of milbemycin oxime.(
2) Cats. Each tablet contains 5.75, 11.5, or 23.0 milligramsmg) of milbemycin oxime.
(b) SponsorSponsors. See Nos. 013744 and 058198 in § 510.600(c) of this chapter.
(d)(c) [Reserved]
and puppiesConditions of use -
(1) Dogs
use-
(i) Amount. For hookworm, roundworm, and whipworm,
milligramadminister 0.23
milligrammg per pound (mg/lb) of body weight (0.5
usemg per kilogram (mg/kg)). For heartworm,
milligram per poundadminister 0.05
milligram per kilogrammg/lb of body weight (0.1
inmg/kg). Administer once a month.
(ii) Indications for use. For prevention of heartworm disease caused by Dirofilaria immitis, control of hookworm infections caused by Ancylostoma caninum, and removal and control of adult roundworm infections caused by Toxocara canis and Toxascaris leonina and whipworm infections caused by Trichuris vulpis in dogs and
ofpuppies 4 weeks of age or greater and 2 pounds
Do not use in puppies less than 4 weeks of age and less than 2 pounds of body weight. Administer once a month. First dose given within 1 month after first exposure to mosquitoes and continue regular use until at least 1 month after end of mosquito season.body weight or greater.
(iii) Limitations.
and kittensFederal law restricts this drug to use by or on the order of a licensed veterinarian.
(2) Cats
milligram per pound-
(i) Amount. Administer 0.91
milligrams per kilogram)mg/lb of body weight (2.0
Do not use in kittens less than 6 weeks of age or 1.5 pounds body weight. Administer once a month.mg/kg) once a month.
(ii) Indications for use. For prevention of heartworm disease caused by Dirofilaria immitis and the removal of adult Toxocara cati (roundworm) and Ancylostoma tubaeforme (hookworm) infections in cats 6 weeks of age or greater and 1.5 pounds body weight or greater.
(iii) Limitations.
Federal law restricts this drug to use by or on the order of a licensed veterinarian.
[55 84 FR 25301, June 21, 1990, as amended at 55 FR 49888, Dec. 3, 1990; 58 FR 5608, Jan. 22, 1993; 60 FR 50097, Sept. 28, 1995; 61 FR 43654, Aug. 26, 1996; 63 FR 29352, May 29, 1998; 63 FR 41189, Aug. 3, 1998. Redesignated at 77 FR 47512, Aug. 9, 201212494, Apr. 2, 2019]