[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 (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
