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Title 21: Food and Drugs
« Home / Title 21 - Food and Drugs--Volume 6 / CHAPTER I - FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) / SUBCHAPTER E - ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS / PART 522 - IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS / § 522.1451 Moxidectin microspheres for injection.
§ 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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