CFR - Code of Federal Regulations Title 21

The information on this page is current as of Mar 22, 2024.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

[Code of Federal Regulations]

[Title 21, Volume 6]

[CITE: 21CFR529.443]

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 529 -- CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS

Sec. 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]