[Federal Register Volume 63, Number 112 (Thursday, June 11, 1998)]
[Rules and Regulations]
[Pages 31931-31932]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-15554]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 510 and 524
Ophthalmic and Topical Dosage Form New Animal Drugs; Gentamicin
Sulfate, Betamethasone Valerate, and Clotrimazole Ointment
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, betamethasone valerate, and clotrimazole
(Tri-Otic ointment) for the treatment of canine acute and chronic
otitis externa associated with yeast and/or bacteria susceptible to
gentamicin.
EFFECTIVE DATE: June 11, 1998.
FOR FURTHER INFORMATION CONTACT: Dianne T. McRae, Center for Veterinary
Medicine (HFV-102), Food and Drug Administration, 7500 Standish Pl.,
Rockville, MD 20855, 301-594-1623.
SUPPLEMENTARY INFORMATION: Med-Pharmex, Inc., 2727 Thompson Creek Rd.,
Pomona, CA 91767, filed ANADA 200-229 that provides for the use of
gentamicin sulfate, betamethasone valerate, and clotrimazole (Tri-Otic
ointment) for the treatment of canine acute and chronic otitis externa
associated with yeast and/or bacteria susceptible to gentamicin.
The ANADA is approved as a generic copy of Schering Plough Animal
Health Corp.'s NADA 140-896 for OTOMAX (gentamicin sulfate,
betamethasone valerate, and clotrimazole). ANADA 200-229 is approved as
of April 8, 1998, and the regulations are amended in 21 CFR 524.1044g
to reflect the approval. The basis for approval is discussed in the
freedom of information summary. In addition, the agency is amending 21
CFR 510.600(c)( 1) and (c)(2) to reflect a change of sponsor's name and
address.
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 25.33(d)(1) 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
21 CFR Part 510
Administrative practice and procedure, Animal drugs, Labeling,
Reporting and recordkeeping requirements.
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 parts 510 and
524 are amended as follows:
PART 510--NEW ANIMAL DRUGS
1. The authority citation for 21 CFR part 510 continues to read as
follows:
Authority: 21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e.
2. Section 510.600 Names, addresses, and drug labeler codes of
sponsors of approved applications is amended in the table in paragraph
(c)(1) in the entry for ``Med-Pharmex, Inc., Biomed Laboratories'' and
in the table in paragraph (c)(2) in the entry for ``051259'' by
revising the sponsor name and address to read as follows:
Sec. 510.600 Names, addresses, and drug labeler codes of sponsors of
approved applications.
* * * * *
(c) * * *
(1) * * *
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Firm name and address Drug labeler code
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* * * * * *
*
Med-Pharmex, Inc., 2727 Thompson Creek Rd., Pomona, CA 051259
91767-1861
* * * * * *
*
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(2) * * *
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Drug labeler code Firm name and address
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* * * * * *
*
051259 Med-Pharmex, Inc., 2727 Thompson Creek Rd., Pomona, CA
91767-1861
* * * * * *
*
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[[Page 31932]]
PART 524--OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS
3. The authority citation for 21 CFR part 524 continues to read as
follows:
Authority: 21 U.S.C. 360b.
Sec. 524.1044g [Amended]
4. Section 524.1044g Gentamicin sulfate, betamethasone valerate,
clotrimazole ointment is amended in paragraph (b) by removing
``000061'' and adding in its place ``000061 and 051259''.
Dated: May 27, 1998.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 98-15554 Filed 6-10-98; 8:45 am]
BILLING CODE 4160-01-F