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: 21CFR520.666]

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 520 -- ORAL DOSAGE FORM NEW ANIMAL DRUGS

Sec. 520.666 Dirlotapide.

(a) Specifications. Each milliliter (mL) of solution contains 5 milligrams (mg) dirlotapide.

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

(c) Conditions of use in dogs - (1) Amount. The initial dosage is 0.01 mL/kg (0.0045 mL/lb) body weight for the first 14 days. After the first 14 days of treatment, the dose volume is doubled to 0.02 mL/kg (0.009 mL/lb) body weight for the next 14 days (days 15 to 28 of treatment). Dogs should be weighed monthly and the dose volume adjusted every month, as necessary, to maintain a target percent weight loss until the desired weight is achieved.

(2) Indications for use. For the management of obesity.

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

[72 FR 263, Jan. 4, 2007, as amended at 79 FR 28820, May 20, 2014]