21 CFR § 522.1008 - Frunevetmab.
§ 522.1008 Frunevetmab.
(a) Specifications. Each milliliter (mL) of solution contains 7 milligrams (mg) frunevetmab.
(b) Sponsor. See No. 054771 in § 510.600(c) of this chapter.
(c) Conditions of use—(1) Cats—(i) Amount. Administer once a month by subcutaneous injection the full contents of one or two 1-mL vials to achieve a minimum dosage of 0.45 mg/lb (1 mg/kg) body weight.
(ii) Indications for use. For the control of pain associated with osteoarthritis in cats.
(iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(2) [Reserved]
[87 FR 58962, Sept. 29, 2022]