[Federal Register Volume 67, Number 166 (Tuesday, August 27, 2002)]
[Rules and Regulations]
[Pages 54954-54955]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-21733]



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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

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 (NADAs) filed by Pharmacia and Upjohn Co. for 
clindamycin hydrochloride oral dosage forms. The supplement to the NADA 
for an oral liquid provides for an expanded dose range for the use of 
clindamycin hydrochloride in both dogs and cats for the treatment of 
certain bacterial infections. The supplement to the NADA for oral 
capsules provides for an expanded dose range in dogs and for use of a 
300-milligram (mg) strength capsule.

DATES: This rule is effective August 27, 2002.

FOR FURTHER INFORMATION CONTACT: Melanie R. Berson, Center for 
Veterinary Medicine (HFV-110), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-7540, e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION: Pharmacia and Upjohn Co., 7000 Portage Rd., 
Kalamazoo, MI 49001-0199, filed supplements to NADA 135-940 that 
provides for use of ANTIROBE (clindamycin hydrochloride) Aquadrops 
Liquid and to NADA 120-161 for ANTIROBE (clindamycin hydrochloride) 
Capsules. Supplemental NADA 135-940 provides for an expanded dose range 
for the use of clindamycin hydrochloride in both dogs and cats for the 
treatment of certain infections associated with bacteria susceptible to 
clindamycin hydrochloride. Supplemental NADA 120-161 provides for the 
same expanded dose range in dogs and for use of a 300-mg strength 
capsule. The supplemental applications are approved as of May 13, 2002, 
and the regulations are amended in Secs. 520.446 and 520.447 (21 CFR 
520.446 and 520.447) to reflect these approvals. The basis of these 
approvals is discussed in the freedom of information summaries. 
Sections 520.446 and 520.447 are also being revised to reflect a 
current format.
    In accordance with the freedom of information provisions of 21 CFR 
part 20 and 514.11(e)(2)(ii), summaries of safety and effectiveness 
data and information submitted to support approval of these 
applications may be seen in the Dockets Management Branch (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(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 environmental 
assessments nor environmental impact statements are 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 Subject 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 520.446 is revised to read as follows:


Sec. 520.446  Clindamycin capsules and tablets.

    (a) Specifications--(1) Each capsule contains the equivalent of 25, 
75, 150, or 300 milligrams (mg) clindamycin as the hydrochloride salt.
    (2) Each capsule contains the equivalent of 25, 75, or 150 mg 
clindamycin as the hydrochloride salt.
    (3) Each tablet contains the equivalent of 25, 75, or 150 mg 
clindamycin as the hydrochloride salt.
    (b) Sponsors. See sponsors in Sec. 510.600(c) of this chapter as 
follows:
    (1) No. 000009 for use of capsules described in paragraph (a)(1) of 
this section as in paragraphs (d)(1)(i) and (d)(2)(i) of this section.
    (2) No. 059130 for use of capsules described in paragraph (a)(2) of 
this section as in paragraphs (d)(1)(ii) and (d)(2)(ii) of this 
section.
    (3) No. 059079 for use of tablets described in paragraph (a)(3) of 
this section as in paragraphs (d)(1)(ii) and (d)(2)(ii) of this 
section.
    (c) Special considerations. Federal law restricts this drug to use 
by or on the order of a licensed veterinarian.
    (d) Conditions of use in dogs--(1) Amount--(i) Wounds, abscesses, 
and dental infections: 2.5 to 15 mg per pound (/lb) of body weight 
every 12 hours for a maximum of 28 days. Osteomyelitis: 5.0 to 15 mg/lb 
of body weight every 12 hours for a minimum of 28 days.
    (ii) Wounds, abscesses, and dental infections: 2.5 mg/lb of body 
weight every 12 hours for a maximum of 28 days. Osteomyelitis: 5.0 mg/
lb of body weight every 12 hours for a minimum of 28 days.
    (2) Indications for use--(i) 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.
    (ii) For the treatment of soft tissue infections (wounds and 
abscesses), dental infections, and osteomyelitis caused by susceptible 
strains of S. aureus, soft tissue infections (deep wounds and 
abscesses), dental infections, and osteomyelitis caused by or 
associated with susceptible strains of B. fragilis, P. melaninogenicus, 
F. necrophorum, and C. perfringens.
    3. Section 520.447 is revised to read as follows:


Sec. 520.447  Clindamycin liquid.

    (a) Specifications. Each milliliter of solution contains the 
equivalent of 25 milligrams (mg) clindamycin as the hydrochloride salt.
    (b) Sponsors. See sponsors in Sec. 510.600(c) of this chapter as 
follows:
    (1) No. 000009 for use as in paragraphs (d)(1)(i)(A), 
(d)(1)(ii)(A), (d)(2)(i)(A), and (d)(2)(ii)(A) of this section.
    (2) No. 059130 for use as in paragraphs (d)(1)(i)(B), 
(d)(1)(ii)(B), (d)(2)(i)(B), and (d)(2)(ii)(B) of this section.
    (c) Special considerations. Federal law restricts this drug to use 
by  or on the order of a licensed veterinarian.
    (d) Conditions of use--(1) Dogs--(i) Amount--(A) Wounds, abscesses, 
and dental infections: 2.5 to 15 mg per

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pound (/lb) of body weight every 12 hours for a maximum of 28 days. 
Osteomyelitis: 5.0 to 15 mg/lb of body weight every 12 hours for a 
minimum of 28 days.
    (B) Wounds, abscesses, and dental infections: 2.5 mg per pound (/
lb) of body weight every 12 hours for a maximum of 28 days. 
Osteomyelitis: 5.0 mg/lb of body weight every 12 hours for a minimum of 
28 days.
    (ii) Indications for use--(A) 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.
    (B) For the treatment of soft tissue infections (wounds and 
abscesses), dental infections, and osteomyelitis caused by susceptible 
strains of S. aureus and for soft tissue infections (deep wounds and 
abscesses), dental infections, and osteomyelitis caused by or 
associated with susceptible strains of B. fragilis, P. melaninogenicus, 
F. necrophorum, and C. perfringens.
    (2) Cats--(i) Amount--(A) 5.0 to 15.0 mg/lb of body weight every 24 
hours for a maximum of 14 days.
    (B) 5.0 to 10.0 mg/lb of body weight every 24 hours for a maximum 
of 14 days.
    (ii) Indications for use--(A) For the treatment of skin infections 
(wounds and abscesses) due to susceptible strains of S. aureus, S. 
intermedius, Streptococcus spp., deep wounds and abscesses due to 
susceptible strains of Clostridium perfringens and Bacteroides 
fragilis, and dental infections due to susceptible strains of S. 
aureus, S. intermedius, Streptococcus spp., C. perfringens, and B. 
fragilis.
    (B) Aerobic bacteria: Treatment of soft tissue infections (wounds 
and abscesses) and dental infections caused by or associated with 
susceptible strains of S. aureus, S. intermedius, and Streptococcus 
spp. Anaerobic bacteria: Treatment of soft tissue infections (deep 
wounds and abscesses) and dental infections caused by or associated 
with susceptible strains of C. perfringens and B. fragilis.

    Dated: July 17, 2002.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 02-21733 Filed 8-26-02; 8:45 am]
BILLING CODE 4160-01-S