21 C.F.R. § 522.2075

Current through October 31, 2024
Section 522.2075 - Robenacoxib
(a)Specifications. Each milliliter of solution contains 20 milligrams (mg) robenacoxib.
(b)Sponsor. See No. 058198 in § 510.600(c) of this chapter.
(c)Conditions of use -
(1)Dogs -
(i)Amount. Administer 0.91 mg per pound (2 mg/kilogram (kg)) by subcutaneous injection, once daily, for a maximum of 3 days. After the initial subcutaneous dose, subsequent doses can be given by subcutaneous injection or as the oral tablet in dogs weighing at least 5.5 pounds (2.5 kg) and at least 4 months of age, for a maximum of 3 total doses over 3 days, not to exceed 1 dose per day. See § 520.2075(c)(1) of this chapter.
(ii)Indications for use. For the control of postoperative pain and inflammation associated with soft tissue surgery in dogs at least 4 months of age for a maximum of 3 days.
(iii)Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(2)Cats -
(i)Amount. Administer 0.91 mg per pound (2 mg/kg) by subcutaneous injection, once daily, for a maximum of 3 days.
(ii)Indications for use. For the control of postoperative pain and inflammation associated with orthopedic surgery, ovariohysterectomy, and castration in cats at least 4 months of age for a maximum of 3 days.
(iii)Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

21 C.F.R. §522.2075

80 FR 61297 , Oct. 13, 2015, as amended at 82 FR 12170 , Mar. 1, 2017
As amended at 82 FR 12170, 3/1/2017