§ 516.1012 Fuzapladib.
(a) Specifications. The drug is provided as a powder for injection that is reconstituted with 3.5 milliliter (mL) of provided diluent to a final concentration of 4 milligrams (mg) fuzapladib sodium per mL.
(b) Sponsor. See No. 064642 in § 510.600(c) of this chapter.
(c) Conditions of use—(1) Amount. Administer at a dosage of 0.4 mg (0.1 mL) per kilogram of body weight once daily for 3 consecutive days by intravenous (IV) injection over 15 seconds to 1 minute.
(2) Indications for use in dogs. For the management of clinical signs associated with acute onset of pancreatitis in dogs.
(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. It is a violation of Federal law to use this product other than as directed in the labeling.
[88 FR 16546, Mar. 20, 2023]