CFR - Code of Federal Regulations Title 21

The information on this page is current as of Mar 22, 2024.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

[Code of Federal Regulations]

[Title 21, Volume 6]

[CITE: 21CFR524.775]

TITLE 21--FOOD AND DRUGS

CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES

SUBCHAPTER E - ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS

PART 524 -- OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS

Sec. 524.775 Emodepside and praziquantel.

(a) Specifications. Each milliliter of solution contains 21.4 milligrams (mg) emodepside and 85.7 mg praziquantel.

(b) Sponsor. See No. 058198 in § 510.600(c) of this chapter.

(c) Conditions of use in cats - (1) Amount. The recommended minimum dose is 1.36 mg/pound (lb) (3 mg/kilogram (kg)) emodepside and 5.45 mg/lb (12 mg/kg) praziquantel applied as a single topical dose.

(2) Indications for use. For the treatment and control of hookworm infections caused by Ancylostoma tubaeforme (adults, immature adults, and fourth stage larvae), roundworm infections caused by Toxocara cati (adults and fourth stage larvae), and tapeworm infections caused by Dipylidium caninum (adults) and Taenia taeniaeformis (adults).

(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[72 FR 42291, Aug. 2, 2007, as amended at 86 FR 14820, Mar. 19, 2021]