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522.1451—Moxidectin for suspension.

(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. 000856 in § 510.600(c) of this chapter.

(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.

Code of Federal Regulations

[66 FR 35756, July 9, 2001, as amended at 67 FR 57944, Sept. 13, 2002]

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