Current through October 31, 2024
Section 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