---
kind: "section"
citation: "21 C.F.R. § 516.1012"
title: "21"
number: "516.1012"
heading: "Fuzapladib."
url: "https://uscodex.org/cfr/21/516.1012"
---

# §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)](/cfr/21/510.600.md?p=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.

## Notes

### Amendments

[88 FR 16546, Mar. 20, 2023]

### Source

Source: 72 FR 57200, Oct. 9, 2007, unless otherwise noted.

### Authority

Authority: 21 U.S.C. 360ccc-1, 360ccc-2, 371.

### Source

Source: 72 FR 41017, July 26, 2007, unless otherwise noted.

### Amendments

[88 FR 16546, Mar. 20, 2023]