[Federal Register Volume 62, Number 44 (Thursday, March 6, 1997)]
[Rules and Regulations]
[Page 10220]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-5453]


-----------------------------------------------------------------------


DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Part 524


Ophthalmic and Topical Dosage Form New Animal Drugs; Gentamicin 
Topical Spray

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

-----------------------------------------------------------------------

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 topical spray in dogs for the treatment of infected 
superficial lesions caused by bacteria susceptible to gentamicin.

EFFECTIVE DATE: March 6, 1997.

FOR FURTHER INFORMATION CONTACT: Elizabeth Reese, 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 91767-1861, filed ANADA 200-188, which provides for 
Gentaspray<SUP>TM Topical Spray (each milliliter contains gentamicin 
sulfate equivalent to 0.57 milligram (mg) gentamicin, betamethasone 
valerate equivalent to 0.284 mg betamethasone) to be used topically for 
the treatment of infected superficial lesions in dogs caused by 
bacteria susceptible to gentamicin.
    Approval of ANADA 200-188 for Med-Pharmex, Inc. 's, 
Gentaspray<SUP>TM Topical Spray (gentamicin sulfate with betamethasone 
valerate) is as a generic copy of Schering Plough's NADA 132-338 
Gentocin<Register> Topical Spray (gentamicin sulfate with betamethasone 
valerate). The ANADA is approved as of January 29, 1997, and the 
regulations in 21 CFR 524.1044f(b) are amended 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 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.
    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).

    2. Section 524.1044f is amended by revising paragraph (b) to read 
as follows:

Sec. 524.1044f  Gentamicin sulfate, betamethasone valerate topical 
spray.

* * * * *
    (b) Sponsor. See Nos. 000061 and 051259 in Sec. 510.600(c) of this 
chapter.
* * * * *

    Dated: February 11, 1997.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 97-5453 Filed 3-5-97; 8:45 am]
BILLING CODE 4160-01-F