[Federal Register Volume 63, Number 52 (Wednesday, March 18, 1998)]
[Rules and Regulations]
[Page 13121]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-6907]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 520
Oral Dosage Form New Animal Drugs; Amoxicillin Trihydrate and
Clavulanate Potassium
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 two supplemental new animal
drug applications (NADA's) filed by Pfizer, Inc. The supplemental
NADA's provide for oral use amoxicillin trihydrate and clavulanate
potassium tablets and suspension for treatment of dogs for periodontal
infections due to susceptible strains of aerobic and anaerobic
bacteria.
EFFECTIVE DATE: March 18, 1998.
FOR FURTHER INFORMATION CONTACT: Mary E. Reese, Center for Veterinary
Medicine (HFV-114), Food and Drug Administration, 7500 Standish Pl.,
Rockville, MD 20857, 301-594-1617.
SUPPLEMENTARY INFORMATION: Pfizer, Inc., 235 East 42d St., New York, NY
10017, filed supplemental NADA's 55-099 and 55-101 that provide for
oral use of amoxicillin trihydrate and clavulanate potassium tablets
and suspension for treatment of dogs for periodontal infections due to
susceptible strains of aerobic and anaerobic bacteria. The products are
limited to use by or on the order of a licensed veterinarian. The
supplemental NADA's are approved as of December 23, 1997, and the
regulations are amended in 21 CFR 520.88g and 520.88h 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 the supplemental
applications may be seen in the Dockets Management Branch (HFA-305),
Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23, Rockville,
MD 20857, from 9 a.m. to 4 p.m., Monday through Friday.
Under section 512(c)(2)(F)(iii) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(iii)), these approvals for
nonfood-producing animals qualify for 3 years of marketing exclusivity
beginning December 23, 1997, because the supplemental applications
contain substantial evidence of the effectiveness of the drug involved,
or any studies of animal safety, required for approval of the
applications and conducted or sponsored by the applicant. Three years
of marketing exclusivity applies only to use of Clavamox
tablets and suspension in dogs for treatment of periodontal infections
caused by susceptible strains of aerobic and anaerobic bacteria.
FDA has determined under 21 CFR 25.33(d)(1) that these actions are
of a type that do 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: 21 U.S.C. 360b.
2. Section 520.88g is amended in paragraph (c)(1)(ii) by adding a
new sentence at the end of the paragraph to read as follows:
Sec. 520.88g Amoxicillin trihydrate and clavulanate potassium film-
coated tablets.
* * * * *
(c) * * *
(1) * * *
(ii) * * * Treatment of periodontal infections due to susceptible
strains of aerobic and anaerobic bacteria.
* * * * *
3. Section 520.88h is amended in paragraph (c)(1)(ii) by adding a
new sentence at the end of the paragraph to read as follows:
Sec. 520.88h Amoxicillin trihydrate and clavulanate potassium for oral
suspension.
* * * * *
(c) * * *
(1) * * *
(ii) * * * Treatment of periodontal infections due to susceptible
strains of aerobic and anaerobic bacteria.
* * * * *
Dated: February 27, 1998.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 98-6907 Filed 3-17-98; 8:45 am]
BILLING CODE 4160-01-F