[Federal Register Volume 62, Number 181 (Thursday, September 18, 1997)]
[Rules and Regulations]
[Page 48940]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-24850]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 524


Ophthalmic and Topical Dosage Form New Animal Drugs; Cyclosporine

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is amending the animal 
drug regulations to reflect approval of a supplemental new animal drug 
application (NADA) filed by Schering-Plough Animal Health. The 
supplemental NADA provides for use of cyclosporine ophthalmic ointment 
on dogs for management of chronic superficial keratitis (CSK) and 
changing the approved label claim to management of chronic 
keratoconjunctivitis sicca (KCS).

EFFECTIVE DATE: September 18, 1997.

FOR FURTHER INFORMATION CONTACT: Melanie R. Berson, Center for 
Veterinary Medicine (HFV-110), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-594-1612.

SUPPLEMENTARY INFORMATION: Schering-Plough Animal Health, Schering-
Plough Corp., P.O. Box 529, Kenilworth, NJ 07033, has filed 
supplemental NADA 141-052 Optimmune<Register> (cyclosporine) ophthalmic 
ointment that provides for use on dogs for the management of chronic 
superficial keratitis (CSK) and changing the approved label claim from 
treatment to management of chronic keratoconjunctivitis sicca (KCS) in 
dogs. The term management reflects the complexity of the therapy for 
the diseases. The drug is limited to use by or on the order of a 
licensed veterinarian. The supplement is approved as of August 26, 
1997, and the regulations are revised in 21 CFR 524.575(c)(2) to 
reflect the approval. The basis of approval is discussed in the freedom 
of information summary.
    In accordance with the freedom of information provisions of 21 CFR 
part 20 and 514.11(e)(2)(ii), a summary of safety and effectiveness 
data and information submitted to support approval of this application 
may be seen in the Dockets Management Branch (HFA-305), Food and Drug 
Administration, 12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857, 
between 9 a.m. and 4 p.m., Monday through Friday.
    Under section 512(c)(2)(F)(iii) of the Federal Food, Drug, and 
Cosmetic Act, this approval for use in nonfood-producing animals 
qualifies for 3 years of marketing exclusivity beginning August 26, 
1997, because the supplemental application contains substantial 
evidence of the effectiveness of the drug involved, studies of animal 
safety or, in the case of food-producing animals, human food safety 
studies (other than bioequivalence or residue studies) required for 
approval of the application and conducted or sponsored by the 
applicant. The 3 years of marketing exclusivity applies only to the new 
indication for management of CSK in dogs.
    FDA has carefully considered the potential environmental effects of 
this action and has concluded that the action will not have a 
significant impact on the human environment, and that an environmental 
impact statement is not required. FDA's finding of no significant 
impact and the evidence supporting that finding, contained in an 
environmental assessment, may be seen in the Dockets Management Branch 
(address above).

List of Subjects in 21 CFR Part 524

    Animal drugs.
    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs and 
redelegated to the Center for Veterinary Medicine, 21 CFR part 524 is 
amended as follows:

PART 524--OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS

    1. The authority citation for 21 CFR part 524 continues to read as 
follows:

    Authority: Sec. 512 of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 360b).

    2. Section 524.575 is amended by revising paragraph (c)(2) to read 
as follows:


Sec. 524.575  Cyclosporine ophthalmic ointment.

* * * * *
    (c) * * *
    (2) Indications for use. For management of chronic 
keratoconjunctivitis sicca (KCS) and chronic superficial keratitis 
(CSK) in dogs.
* * * * *

    Dated: September 10, 1997.
Michael J. Blackwell,
Deputy Director, Center for Veterinary Medicine.
[FR Doc. 97-24850 Filed 9-17-97; 8:45 am]
BILLING CODE 4160-01-F