[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]
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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.
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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 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
GentasprayTM 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,
GentasprayTM Topical Spray (gentamicin sulfate with betamethasone
valerate) is as a generic copy of Schering Plough's NADA 132-338
Gentocin 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
