02-21733. Oral Dosage Form New Animal Drugs; Clindamycin

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Final rule.

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: [e-mail].

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 §§ 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:

§ 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 § 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:

§ 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 § 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 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.