§520.1189. Itraconazole.

21 C.F.R. § 520.1189

(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.

Notes, amendments, and revision history

[82 FR 12169, Mar. 1, 2017, as amended at 86 FR 57996, Oct. 20, 2021]

Authority: 21 U.S.C. 360b.

Source: 40 FR 13838, Mar. 27, 1975, unless otherwise noted.

[82 FR 12169, Mar. 1, 2017, as amended at 86 FR 57996, Oct. 20, 2021]