GroundRules
21 CFR 516.1449: Molidustat oral suspension.
Where this section sits in the code
- Title 21—Food and Drugs
- CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
- SUBCHAPTER E—ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS
- PART 516—NEW ANIMAL DRUGS FOR MINOR USE AND MINOR SPECIES
- Subpart E—Conditionally Approved New Animal Drugs For Minor Use and Minor Species
(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.
Collected 2026-08-27T02:24:47Z. Source file · JSON