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Oral Dosage Form New Animal Drugs; Clindamycin Capsules and Tablets

 [Federal Register: July 12, 2006 (Volume 71, Number 133)]
[Rules and Regulations]
[Page 39203-39204]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr12jy06-2]

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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 Capsules and Tablets

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 a supplemental abbreviated new 
animal drug application (ANADA) filed by Virbac AH, Inc. The 
supplemental ANADA provides for an expanded dose range and revised 
wording of indications for the oral use of clindamycin hydrochloride 
tablets in dogs for the treatment of certain bacterial diseases.

DATES: This rule is effective July 12, 2006.

FOR FURTHER INFORMATION CONTACT: Daniel A. Benz, Center for Veterinary 
Medicine (HFV-104), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 301-827-0223, e-mail: daniel.benz@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Virbac AH, Inc., 3200 Meacham Blvd., Ft. 
Worth, TX 76137, filed a supplement to ANADA 200-316 for CLINITABS 
(clindamycin hydrochloride) tablets for the treatment of certain 
bacterial diseases in dogs. The supplemental ANADA provides for an 
expanded dose range and revised wording of indications. The 
supplemental ANADA is approved as of June 2, 2006, and the regulations 
are amended in 21 CFR 520.446 to reflect the approval and a current format.

[[Page 39204]]

    Approval of this supplemental ANADA did not require review of 
additional safety or effectiveness data or information. Therefore, a 
freedom of information summary is not required.
    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.  520.446, revise paragraphs (b)(1) and (b)(2); remove 
paragraph (c); redesignate paragraph (d) as paragraph (c); and revise 
newly redesignated paragraph (c) to read as follows:

Sec.  520.446  Clindamycin capsules and tablets.

* * * * *
    (b) * * *
    (1) Nos. 000009 and 059130 for use of capsules described in 
paragraph (a)(1) of this section.
    (2) No. 051311 for use of tablets described in paragraph (a)(2) of 
this section.
    (c) Conditions of use in dogs--(1) Amount. Wounds, abscesses, and 
dental infections: 2.5 to 15 mg per pound (/lb) body weight every 12 
hours for a maximum of 28 days. Osteomyelitis: 5.0 to 15 mg/lb body 
weight every 12 hours for a minimum of 28 days.
    (2) Indications for use. For the treatment of skin infections 
(wounds and abscesses) due to susceptible strains of coagulase-positive 
staphylococci (Staphylococcus aureus or S. intermedius), deep wounds 
and abscesses due to susceptible strains of Bacteroides fragilis, 
Prevotella melaninogenicus, Fusobacterium necrophorum, and Clostridium 
perfringens, dental infections due to susceptible strains of S. aureus, 
B. fragilis, P. melaninogenicus, F. necrophorum, and C. perfringens, 
and osteomyelitis due to susceptible strains of S. aureus, B. fragilis, 
P. melaninogenicus, F. necrophorum, and C. perfringens.
    (3) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.

    Dated: June 27, 2006.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. E6-10877 Filed 7-11-06; 8:45 am]
BILLING CODE 4160-01-S

 
 

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