[Federal Register Volume 61, Number 180 (Monday, September 16, 1996)]
[Rules and Regulations]
[Page 48624]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-23668]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Part 524


Ophthalmic and Topical Dosage Form New Animal Drugs; Gentamicin 
Otic Solution

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 an abbreviated new animal drug 
application (ANADA) filed by Med-Pharmex, Inc. The ANADA provides for 
use of gentamicin sulfate and betamethasone valerate otic solution to 
treat acute and chronic canine otitus externa and canine and feline 
superficial infected lesions caused by bacteria sensitive to 
gentamicin.

EFFECTIVE DATE: September 16, 1996.
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: Med-Pharmex, Inc., 2727 Thompson Creek Rd., 
Pomona, CA 91767, filed ANADA 200-183, which provides for use of 
gentamicin otic solution (gentamicin sulfate equivalent to 3 milligrams 
(mg) gentamicin and betamethasone valerate equivalent to 1 mg 
betamethasone) topically to treat acute and chronic canine otitus 
externa and canine and feline superficial infected lesions caused by 
bacteria sensitive to gentamicin.
    The ANADA is approved as a generic copy of Schering Plough's NADA 
46-821 Gentocin Otic Solution (gentamicin sulfate with betamethasone 
valerate). ANADA 200-183 is approved as of July 31, 1996, and the 
regulations are amended in 21 CFR 524.1044b(b) to reflect the approval. 
The basis for 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, 12420 
Parklawn Dr., rm. 1-23, Rockville, MD 20857, between 9 a.m. and 4 p.m., 
Monday through Friday.
    The agency has determined under 21 CFR 25.24(d)(1)(i) that this 
action is of a type that does not individually or cumulatively have a 
significant effect on the human environment. Therefore, neither an 
environmental assessment nor an environmental impact statement is 
required.

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).

Sec. 524.1044b  [Amended]

    2. Section 524.1044b Gentamicin sulfate, betamethasone valerate 
otic solution is amended in paragraph (b) by removing ``No. 000061'' 
and adding in its place ``Nos. 000061 and 051259''.

    Dated: September 4, 1996.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 96-23668 Filed 9-13-96; 8:45 am]
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