21 C.F.R. § 516.1449

Molidustat oral suspension.

Last amended: 2023Year: 2026Length: 109 wordsSubsections: 3Official source

Cite as 21 C.F.R. § 516.1449 (2026)

(a) Specifications. Each milliliter (mL) of suspension contains 25 milligrams (mg) molidustat sodium. (b) Sponsor. See No. 058198 in § 510.600(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. [88 FR 55563, Aug. 16, 2023]
Cross-references to the CFR
510.600
21 C.F.R. § 516.1449: Molidustat oral suspension. | Justis AI