[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]
BILLING CODE 4160-01-F
