[Federal Register Volume 62, Number 171 (Thursday, September 4, 1997)]
[Rules and Regulations]
[Pages 46668-46669]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-23450]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 520
Oral Dosage Form New Animal Drugs; Clindamycin Hydrochloride
Liquid
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 Phoenix Scientific, Inc. The ANADA
provides for veterinary prescription use in dogs of clindamycin
hydrochloride liquid for therapy of wounds, abscesses, and dental
infections, and therapy of osteomyelitis.
EFFECTIVE DATE: September 4, 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: Phoenix Scientific, Inc., 3915 South 48th
St. Terrace, P.O. Box 6457, St. Joseph, MO 64506-0457, filed ANADA 200-
193 that provides for veterinary prescription use in dogs of
clindamycin hydrochloride liquid for therapy of wounds, abscesses, and
dental infections when administered orally at 2.5 milligrams per pound
(mg/lb) every 12 hours, and for therapy of osteomyelitis when
administered orally at 5.0 mg/lb every 12 hours.
Phoenix Scientific, Inc.'s, ANADA 200-193 clindamycin hydrochloride
liquid is approved as a generic copy of Pharmacia & Upjohn's NADA 135-
940 Antirobe Aquadrops. The ANADA is approved as of August 1,
1997, and the regulations are amended in 21 CFR 520.447(b) to reflect
the approval. The
[[Page 46669]]
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 to 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).
2. Section 520.447 is amended by revising paragraph (b) to read as
follows:
Sec. 520.447 Clindamycin hydrochloride liquid.
* * * * *
(b) Sponsor. See No. 000009 in Sec. 510.600(c) of this chapter for
use as in paragraphs (c) and (d) of this section. See No. 059130 for
use as in paragraph (c) of this section.
* * * * *
Dated: August 22, 1997.
Michael J. Blackwell,
Deputy Director, Center for Veterinary Medicine.
[FR Doc. 97-23450 Filed 9-3-97; 8:45 am]
BILLING CODE 4160-01-F
