21 CFR § 520.666Chapter I

§ 520.666 Dirlotapide.

Primary source

Verbatim text below is from the Electronic Code of Federal Regulations (eCFR), a public-domain U.S. government work. Always verify the current version with the eCFR before relying on it for any legal matter.

Full Text

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

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

Conditions of use in dogsAmount.(c) —(1) 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.

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

Limitations.(3) 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]

eCFR data current as of: June 10, 2026

This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.