21 CFR § 520.666 - Dirlotapide.

---
identifier: "/us/cfr/t21/s520.666"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 520.666 - Dirlotapide."
title_number: 21
title_name: "Food and Drugs"
section_number: "520.666"
section_name: "Dirlotapide."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "E"
subchapter_name: "ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS"
part_number: "520"
part_name: "ORAL DOSAGE FORM NEW ANIMAL DRUGS"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 360b."
regulatory_source: "40 FR 13838, Mar. 27, 1975, unless otherwise noted."
cfr_part: "520"
---


# 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]