21 CFR 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.
(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.