21 CFR 522.1451 - Moxidectin microspheres for injection.

§ 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.

(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; 79 FR 16191, Mar. 25, 2014]

This is a list of United States Code sections, Statutes at Large, Public Laws, and Presidential Documents, which provide rulemaking authority for this CFR Part.

This list is taken from the Parallel Table of Authorities and Rules provided by GPO [Government Printing Office].

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United States Code
U.S. Code: Title 21 - FOOD AND DRUGS

Title 21 published on 09-Jun-2018 03:51

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR Part 522 after this date.

  • 2018-04-05; vol. 83 # 66 - Thursday, April 5, 2018
    1. 83 FR 14584 - New Animal Drugs; Approval of New Animal Drug Applications; Changes of Sponsorship; Change of a Sponsor's Name and Address
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final rule.
      This rule is effective April 5, 2018.
      21 CFR Parts 510, 520, 522, 526, and 558