§ 522.1451 - Moxidectin microspheres for injection.

§ 522.1451 Moxidectin microspheres for injection.

(a) Specifications. The drug product consists of two separate vials. One vial contains 10 percent moxidectin microspheres , and the other second vial contains a vehicle for constitution of the moxidectin microspheres.

(1) Each milliliter (mL) of constituted

, sustained-release

suspension contains 3.4 milligrams (mg) moxidectin.

(2) Each mL of constituted suspension contains 10 mg moxidectin.

(b) Sponsor. See No. 054771 54771 in § 510.600(c) of this chapter.

(c) [Reserved]

(d)

Conditions of use

;

in dogs -

(1) Amount.

0.17 mg per kilogram

(i) Using the suspension described in paragraph (a)(1) of this section, administer 0.05 mL of the constituted suspension per kilogram (kg) of body weight (0.

0773 mg

023 mL per pound (lb)) as a single subcutaneous injection to provide 0.17 mg/kg body weight (0.0773 mg/lb).

(ii) Using the suspension described in paragraph (a)(2) of this section, administer 0.05 mL of the constituted suspension/kg of body weight (0.023 mL/lb) as a single subcutaneous injection to provide 0.5 mg/kg body weight (0.23 mg/lb).

(2) Indications for use -

(i) Suspension described in paragraph (a)(1) of this section. For prevention of heartworm disease caused by Dirofilaria immitis in dogs 6 months of age and older; and for treatment of existing larval and adult hookworm (Ancylostoma caninum and Uncinaria stenocephala) infections.

(ii) Suspension described in paragraph (a)(2) of this section. For prevention of heartworm disease caused by Dirofilaria immitis for 12 months in dogs 12 months of age and older; and 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 85 FR 35756, July 9, 2001, as amended at 67 FR 57944, Sept. 13, 2002; 79 FR 16191, Mar. 25, 20144208, Jan. 24, 2020]