[Federal Register Volume 62, Number 122 (Wednesday, June 25, 1997)]
[Rules and Regulations]
[Pages 34168-34169]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-16686]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 520
Oral Dosage Form New Animal Drugs; Gentamicin Sulfate Oral
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
the use of gentamicin sulfate oral solution for the control and
treatment of colibacillosis in weanling swine and for the control and
treatment of swine dysentery caused by Treponema hyodysenteriae.
EFFECTIVE DATE: June 25, 1997.
FOR FURTHER INFORMATION CONTACT: Lonnie W. Luther, Center for
Veterinary Medicine (HFV-102), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-827-0209.
SUPPLEMENTARY INFORMATION: Med-Pharmex, Inc., 2727 Thompson Creek Rd.,
Pomona, CA 91767, has filed ANADA 200-190, which provides for the
control and treatment of colibacillosis in weanling swine caused by
strains of Escherichia coli sensitive to gentamicin, and for the
control and treatment of swine dysentery associated with T.
hyodysenteriae.
[[Page 34169]]
ANADA 200-190 is approved as a generic copy of Schering-Plough
Animal Health's Garasin (gentamicin sulfate) oral solution in
NADA 91-191. The ANADA is approved as of May 27, 1997, and the
regulations are amended in 21 CFR 520.1044a(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 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 520
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 520 is
amended as follows:
PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS
1. The authority citation for 21 CFR part 520 continues to read as
follows:
Authority: Sec. 512 of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 360b).
Sec. 520.1044a [Amended]
2. Section 520.1044a Gentamicin sulfate oral solution is amended in
paragraph (b) by removing ``No. 000061'' and adding in its place ``Nos.
000061 and 051259''.
Dated: June 12, 1997.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 97-16686 Filed 6-24-97; 8:45 am]
BILLING CODE 4160-01-F
