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Oral Dosage Form New Animal Drugs; Clindamycin Solution

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[Federal Register: April 20, 2007 (Volume 72, Number 76)]
[Rules and Regulations]
[Page 19796]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr20ap07-6]

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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 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 First Priority, Inc. The ANADA provides
for the veterinary prescription use of clindamycin hydrochloride oral
solution in dogs and cats for the treatment of various infections due
to susceptible bacterial pathogens.

DATES:  This rule is effective April 20, 2007.

FOR FURTHER INFORMATION CONTACT:  John K. Harshman, Center for
Veterinary Medicine (HFV-104), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-827-0169, e-mail: 
john.harshman@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: First Priority, Inc., 1585 Todd Farm Dr.,
Elgin, IL 60123, filed ANADA 200-398 for the veterinary prescription
use of Clindamycin Hydrochloride Oral Drops in dogs and cats for the
treatment of various infections due to susceptible bacterial pathogens.
First Priority, Inc.'s Clindamycin Hydrochloride Oral Drops is approved
as a generic copy of ANTIROBE AQUADROPS Liquid, sponsored by Pharmacia
& Upjohn Co., a Division of Pfizer, Inc., under NADA 135-940. The ANADA
is approved as of March 19, 2007, and 21 CFR 520.447 is amended to
reflect the approval.
    In accordance with the freedom of information provisions of 21 CFR
part 20 and 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 Division of Dockets Management
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday through Friday.
    FDA has determined under 21 CFR 25.33(a)(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.
    This rule does not meet the definition of ``rule'' in 5 U.S.C.
804(3)(A) because it is a rule of ``particular applicability.''
Therefore, it is not subject to the congressional review requirements
in 5 U.S.C. 801-808.

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. In Sec.  520.447 revise paragraph (b) to read as follows:

Sec.  520.447   Clindamycin Solution.

* * * * *
    (b) Sponsors. See Nos. 000009, 051311, 058829, and 059130 in Sec. 
510.600(c) of this chapter.
* * * * *

    Dated: April 9, 2007.
Bernadette Dunham,
Deputy Director, Center for Veterinary Medicine.
[FR Doc. E7-7472 Filed 4-19-07; 8:45 am]
BILLING CODE 4160-01-S

 
 

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