21 C.F.R. § 522.1451 Moxidectin for suspension.
Title 21 - Food and Drugs
(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. [66 FR 35756, July 9, 2001, as amended at 67 FR 57944, Sept. 13, 2002]
Title 21: Food and Drugs
PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
§ 522.1451 Moxidectin for suspension.
