---
kind: "section"
citation: "21 C.F.R. § 522.1451"
title: "21"
number: "522.1451"
heading: "Moxidectin microspheres for injection."
url: "https://uscodex.org/cfr/21/522.1451"
---

# §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 second vial contains a vehicle for constitution of the moxidectin microspheres.
  - (1) Each milliliter (mL) of constituted suspension contains 3.4 milligrams (mg) moxidectin.
  - (2) **Each mL of constituted suspension contains 10 mg moxidectin.**
- (b) **Sponsor.** See No. 54771 in [§ 510.600(c)](/cfr/21/510.600.md?p=c) of this chapter.
- (c) **Conditions of use in dogs—**
  - (1) **Amount.**
    - (i) Using the suspension described in [paragraph (a)(1)](#a-1) of this section, administer 0.05 mL of the constituted suspension per kilogram (kg) of body weight (0.023 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)](#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.

## Notes

### Amendments

[85 FR 4208, Jan. 24, 2020]

### Authority

Authority: 21 U.S.C. 360b.

### Source

Source: 40 FR 13858, Mar. 27, 1975, unless otherwise noted.

### Amendments

[85 FR 4208, Jan. 24, 2020]