[Federal Register Volume 68, Number 132 (Thursday, July 10, 2003)]
[Notices]
[Pages 41161-41162]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-17438]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Notice of Approval of New Animal Drug Applications; Bacitracin; 
Lasalocid; Narasin; Roxarsone

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is providing notice 
that in 2002 it approved two original abbreviated new animal drug 
applications (ANADAs) for clindamycin hydrochloride oral dosage forms 
for dogs that were not the subject of final rules. Final rules were not 
published because the drug-specific section of the regulation did not 
require amendment.

FOR FURTHER INFORMATION CONTACT: Lonnie W. Luther, Center for 
Veterinary Medicine (HFV-104), Food and Drug Administration, 7519 
Standish Pl., Rockville, MD 20855, 301-827-8549, e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION: In accordance with section 512(i) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360b(i)) and 21 CFR 
514.105(a) and 514.106(a), FDA is providing notice that in 2002 it 
approved two original ANADAs for clindamycin hydrochloride oral dosage 
forms for dogs that were not the subject of final rules. Final rules 
were not published because 21 CFR 520.446 did not require amendment.
    On June 6, 2001, FDA approved original ANADA 200-316 filed by 
Delmarva Laboratories, Inc., 2200 Wadebridge Rd., P.O. Box 525, 
Midlothian, VA 23113, for the veterinary prescription use of CLINTABS 
(clindamycin hydrochloride) Tablets in dogs. On June 14, 2002, FDA 
approved original ANADA 200-298 filed by Phoenix Scientific, Inc., 3915 
South 48th St. Terrace, P.O. Box 6457, St. Joseph, MO 64506-0457, for 
the veterinary prescription use of

[[Page 41162]]

Clindamycin Hydrochloride Capsules in dogs.
    Both Delmarva Laboratories' CLINTABS Tablets and Phoenix 
Scientific's Clindamycin Hydrochloride Capsules are approved for the 
for treatment of soft tissue infections (wounds and abscesses), dental 
infections, and osteomyelitis caused by susceptible strains of 
Staphylococcus aureus, soft tissue infections (deep wounds and 
abscesses), dental infections, and osteomyelitis caused by or 
associated with susceptible strains of Bacteroides fragilis, 
Bacteroides melaninogenicus, Fusobacterium necrophorum, and Clostridium 
perfringens as generic copies of Pharmacia & Upjohn's ANTIROBE 
Capsules, approved under NADA 120-161. The necessary amendments adding 
these sponsors' drug label codes to 21 CFR 520.446 were made in a final 
rule (67 FR 54954, August 27, 2002) for the approval of an unrelated 
supplemental NADA for the pioneer product.
    Freedom of information summaries containing approved product 
labeling 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.

    Dated: June 25, 2003.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 03-17438 Filed 7-9-03; 8:45 am]
BILLING CODE 4160-01-S