[Federal Register Volume 60, Number 182 (Wednesday, September 20, 1995)]
[Rules and Regulations]
[Page 48651]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-23247]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES
 21 CFR Part 524


 Ophthalmic and Topical Dosage Form New Animal Drugs; 
Cyclosporine Ophthalmic Ointment

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 new animal drug application 
(NADA) filed by Schering-Plough Animal Health Corp. The NADA provides 
for use of cyclosporine ophthalmic ointment for treatment of chronic 
keratoconjunctivitis sicca in dogs.

EFFECTIVE DATE: October 20, 1995.

FOR FURTHER INFORMATION CONTACT: Sandra K. Woods, Center for Veterinary 
Medicine (HFV-114), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 301-594-1617.

SUPPLEMENTARY INFORMATION: Schering-Plough Animal Health Corp., P.O. 
Box 529, Galloping Hill Rd., Kenilworth, NJ 07033, filed NADA 141-052, 
which provides for use of Optimmune (0.2 percent 
cyclosporine, USP) Ophthalmic Ointment for treatment of chronic 
keratoconjunctivitis sicca in dogs. The drug product is available on a 
prescription basis. The NADA is approved as of August 2, 1995, and the 
regulations are amended in part 524 (21 CFR part 524) by adding new 
Sec. 524.575 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 part 20 
(21 CFR part 20) and Sec. 514.11(e)(2)(ii) (21 CFR 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, rm. 1-23, 
12420 Parklawn Dr., Rockville, MD 20857, between 9 a.m. and 4 p.m., 
Monday through Friday.
     Under section 512(c)(2)(F)(i) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(i)), this approval qualifies for 
5 years of marketing exclusivity beginning August 2, 1995, because no 
active ingredient (including any ester or salt of the active 
ingredient) of the drug has been approved in any other application 
under section 512(b)(1) of the act.
    The agency has carefully considered the potential environmental 
effects of this action. FDA has concluded that the action will not have 
a significant impact on the human environment, and that an 
environmental impact statement is not required. The agency'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) between 9 a.m. and 4 p.m., Monday 
through Friday.

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. New Sec. 524.575 is added to read as follows:


Sec. 524.575  Cyclosporine ophthalmic ointment.

     (a) Specifications. Each gram of ointment contains 2 milligrams of 
cyclosporine.
     (b) Sponsor. See No. 000061 in Sec. 510.600(c) of this chapter.
     (c) Conditions of use--(1) Amount. Apply a 1/4-inch strip of 
ointment to the affected eye(s) every 12 hours.
     (2) Indications for use. For treatment of chronic 
keratoconjunctivitis sicca in dogs.
     (3) Limitations. Place ointment directly on cornea or into the 
conjunctival sac. Safety of use in puppies, pregnant or breeding 
animals has not been determined. Federal law restricts this drug to use 
by or on the order of a licensed veterinarian.

    Dated: September 1, 1995.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 95-23247 Filed 9-19-95; 8:45 am]
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