- (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]