21 CFR § 529.443 - Ciclesonide.

§ 529.443 Ciclesonide.

(a) Specifications. A non-pressurized metered dose inhaler and drug cartridge combination containing a solution of 30 milligrams/milliliter of the prodrug ciclesonide. Each actuation releases 343 micrograms (mcg) of ciclesonide.

(b) Sponsor. See No. 000010 in § 510.600(c) of this chapter.

(c) Conditions of use—(1) Amount. Administer an initial dose of 8 actuations (2,744 mcg ciclesonide) twice daily for 5 days, followed by 12 actuations (4,116 mcg ciclesonide) once daily for 5 days.

(2) Indications for use. For the management of clinical signs associated with severe equine asthma.

(3) Limitations. Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[86 FR 13188, Mar. 8, 2021]