21 CFR § 516.1012 - Fuzapladib.

---
identifier: "/us/cfr/t21/s516.1012"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 516.1012 - Fuzapladib."
title_number: 21
title_name: "Food and Drugs"
section_number: "516.1012"
section_name: "Fuzapladib."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "E"
subchapter_name: "ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS"
part_number: "516"
part_name: "NEW ANIMAL DRUGS FOR MINOR USE AND MINOR SPECIES"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 360ccc-1, 360ccc-2, 371."
regulatory_source: "72 FR 41017, July 26, 2007, unless otherwise noted."
cfr_part: "516"
---


# 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]