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Electronic Code of Federal Regulations

e-CFR data is current as of December 12, 2019

Title 21Chapter ISubchapter EPart 522 → §522.1451


Title 21: Food and Drugs
PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS


§522.1451   Moxidectin microspheres for injection.

(a) Specifications. The drug product consists of two separate vials. One contains 10 percent moxidectin microspheres, and the other contains a vehicle for constitution of the moxidectin microspheres. Each milliliter of constituted, sustained-release suspension contains 3.4 milligrams (mg) of moxidectin.

(b) Sponsor. See No. 054771 in §510.600(c) of this chapter.

(c) [Reserved]

(d) Conditions of use; dogs—(1) Amount. 0.17 mg per kilogram body weight (0.0773 mg per pound) as a single subcutaneous injection.

(2) Indications for use. For prevention of heartworm disease caused by Dirofilaria immitis; for treatment of existing larval and adult hookworm (Ancylostoma caninum) and Uncinaria stenocephala infections.

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

[66 FR 35756, July 9, 2001, as amended at 67 FR 57944, Sept. 13, 2002; 79 FR 16191, Mar. 25, 2014]

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