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21 C.F.R. § 520.1445   Milbemycin oxime tablets.

Title 21 - Food and Drugs

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

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§ 520.1445   Milbemycin oxime tablets.

(a) Specifications—(1) Dogs. Each 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 milligrams of milbemycin oxime.

(b) Sponsor. See 058198 in §510.600(c) of this chapter.

(c) [Reserved]

(d) Conditions of use—(1) Dogs and puppies—(i) Amount. For hookworm, roundworm, and whipworm, use 0.23 milligram per pound of body weight (0.5 milligram per kilogram). For heartworm, use 0.05 milligram per pound of body weight (0.1 milligram per kilogram).

(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 in puppies 4 weeks of age or greater and 2 pounds of body weight or greater.

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

(2) Cats and kittens—(i) Amount. 0.91 milligram per pound of body weight (2.0 milligrams per kilogram).

(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. Do not use in kittens less than 6 weeks of age or 1.5 pounds body weight. Administer once a month. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[55 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]

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