CFR - Code of Federal Regulations Title 21

The information on this page is current as of Dec 22, 2023.

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: 21CFR522.1008]

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 522 -- IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

Sec. 522.1008 Frunevetmab.

(a) Specifications. Each milliliter (mL) of solution contains 7 milligrams (mg) frunevetmab.

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

(c) Conditions of use - (1) Cats - (i) Amount. Administer once a month by subcutaneous injection the full contents of one or two 1-mL vials to achieve a minimum dosage of 0.45 mg/lb (1 mg/kg) body weight.

(ii) Indications for use. For the control of pain associated with osteoarthritis in cats.

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

(2) [Reserved]

[87 FR 58962, Sept. 29, 2022]