---
kind: "section"
citation: "21 C.F.R. § 516.1449"
title: "21"
number: "516.1449"
heading: "Molidustat oral suspension."
url: "https://uscodex.org/cfr/21/516.1449"
---

# §516.1449. Molidustat oral suspension.

- (a) **Specifications.** Each milliliter (mL) of suspension contains 25 milligrams (mg) molidustat sodium.
- (b) **Sponsor.** See No. 058198 in [§ 510.600(c)](/cfr/21/510.600.md?p=c) of this chapter.
- (c) **Conditions of use—**
  - (1) **Amount.** Administer orally at a dosage of 5 mg/kg of body weight (2.3 mg/lb) daily for up to 28 consecutive days.
  - (2) **Indications for use.** For the control of nonregenerative anemia associated with chronic kidney disease in cats.
  - (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 55563, Aug. 16, 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 55563, Aug. 16, 2023]