CFR > 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 (parts 500 to 590) > PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS > 522.1451—Moxidectin for suspension.

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.
(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.

Code of Federal Regulations

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