§ 520.1189 Itraconazole.
Primary source
Verbatim text below is from the Electronic Code of Federal Regulations (eCFR), a public-domain U.S. government work. Always verify the current version with the eCFR before relying on it for any legal matter.
Full Text
(a) Specifications. Each milliliter (mL) of solution contains 10 milligrams (mg) of itraconazole.
(b) Sponsor. See No. 051311 in § 510.600(c) of this chapter.
(c) Conditions of use—(1) Amount. Administer 5 mg/kilogram (kg) (0.5 mL/kg) of body weight once daily on alternating weeks for 3 treatment cycles.
(2) Indications for use. For the treatment of dermatophytosis caused by Microsporum canis in cats.
(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
[82 FR 12169, Mar. 1, 2017, as amended at 86 FR 57996, Oct. 20, 2021]
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