[Federal Register Volume 61, Number 225 (Wednesday, November 20, 1996)]
[Rules and Regulations]
[Pages 59002-59003]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-29696]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Parts 510, 520, and 522


Animal Drugs, Feeds, and Related Products; Clindamycin 
Hydrochloride Liquid

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 new animal drug 
application (NADA) filed by Pharmacia & Upjohn Co. The supplemental 
NADA provides for expanding the use of clindamycin hydrochloride liquid 
by adding indications for the treatment of soft tissue infections 
(wounds and abscesses) and dental infections caused by or associated 
with certain, susceptible stains of bacteria in cats.

EFFECTIVE DATE: November 20, 1996.

FOR FURTHER INFORMATION CONTACT: Sandra K. Woods, Center for Veterinary 
Medicine (HFV-114), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 301-594-1617.

SUPPLEMENTARY INFORMATION: Pharmacia & Upjohn Co., 7000 Portage Rd., 
Kalamazoo, MI 49001-0199, is sponsor of NADA 135-940, which provides 
for use of Antirobe Aquadrops Liquid (clindamycin 
hydrochloride) in dogs for treatment of soft tissue infections (wounds 
and abscesses), dental infections, and osteomyelitis caused by or 
associated with certain, susceptible strains of aerobic or anaerobic 
bacteria in accordance with Sec. 520.447 (21 CFR 520.447). The firm has 
filed a supplemental NADA that expands use of the drug product to cats 
by providing for treatment of: (1) Soft tissue infections (wounds and 
abscesses) and dental infections caused by or associated with 
susceptible strains of the aerobic bacteria Staphylococcus aureus, S. 
intermedius, and Streptococcus spp., and (2) soft tissue infections 
(deep wounds and abscesses) and dental infections caused by or 
associated with susceptible strains of the anaerobic bacteria 
Clostridium perfringens and Bacteroides fragilis. The supplemental NADA 
is approved as of October 7, 1996, and the regulations are amended in 
Sec. 520.447 to reflect the approval. The basis for approval is 
discussed in the freedom of information summary.
    In addition, the existing ``Limitations'' paragraph for use of the 
drug in dogs (Sec. 520.447(c)(3)) is being revised to add chinchillas 
and ruminating animals to the list of animals for which the drug 
product is contraindicated.
    Also, the regulations are amended in 21 CFR 510.600(c)(1) and 
(c)(2) and Sec. 522.1145(a) (21 CFR 522.1145(a)) to reflect a change of 
sponsor resulting from the merger of The Upjohn Co. and Pharmacia, Inc. 
The new sponsor, Pharmacia & Upjohn Co., informed FDA of the change and 
subsequently requested that the agency amend the regulation in 
Sec. 522.1145(a) that provides for use of Pharmacia's Hylartin V 
Injection (hyaluronate sodium, NADA 112-048) to indicate the new 
sponsor.
    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 Dockets Management Branch (HFA-
305), Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23, 
Rockville, MD 20857, between 9 a.m. and 4 p.m., Monday through Friday.
    Under section 512(c)(2)(F)(iii) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(iii)), approval for use in cats 
qualifies for 3 years of marketing exclusivity beginning October 7, 
1996, because the application contains reports of new clinical or field 
investigations (other than bioequivalence or residue studies) essential 
to the approval and conducted or sponsored by the applicant.
    The agency has carefully considered the potential environmental 
effects of this action. FDA has concluded that the action will not have 
a significant impact on the human environment, and that an 
environmental impact statement is not required. The agency's finding of 
no significant impact and the evidence supporting that finding, 
contained in an environmental assessment, may be seen in the Dockets 
Management Branch (address above) between 9 a.m. and 4 p.m., Monday 
through Friday.

List of Subjects

21 CFR Part 510

    Administrative practice and procedure, Animal drugs, Labeling, 
Reporting and recordkeeping requirements.

[[Page 59003]]

21 CFR Parts 520 and 522

    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 parts 510, 
520, and 522 are amended as follows:

PART 510--NEW ANIMAL DRUGS

    1. The authority citation for 21 CFR part 510 continues to read as 
follows:

    Authority: Secs. 201, 301, 501, 502, 503, 512, 701, 721 of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321, 331, 351, 352, 
353, 360b, 371, 379e).

    2. Section 510.600 is amended in the table in paragraph (c)(1) by 
removing the entries for ``Pharmacia, Inc.,'' and ``The Upjohn Co.'' 
and by alphabetically adding a new entry for ``Pharmacia & Upjohn Co.'' 
and in the table in paragraph (c)(2) by removing the entry for 
``000016'' and by revising the entry for ``000009'' to read as follows:

Sec. 510.600  Names, addresses, and drug labeler codes of sponsors of 
approved applications.

* * * * *
    (c) * * *
    (1) * * *

                                                                        
------------------------------------------------------------------------
       Firm name and address                  Drug labeler code         
------------------------------------------------------------------------
  *                    *                    *                    *      
                   *                    *                    *          
Pharmacia & Upjohn Co., 7000                                            
 Portage Rd., Kalamazoo, MI 49001-                                      
 0199                                                            000009 
  *                    *                    *                    *      
                   *                    *                    *          
------------------------------------------------------------------------

    (2) * * *

                                                                        
------------------------------------------------------------------------
         Drug labeler code                  Firm name and address       
------------------------------------------------------------------------
  *                    *                    *                    *      
                   *                    *                    *          
000009.............................  Pharmacia & Upjohn Co., 7000       
                                      Portage Rd., Kalamazoo, MI 49001- 
                                      0199                              
  *                    *                    *                    *      
                   *                    *                    *          
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PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS

    3. The authority citation for 21 CFR part 520 continues to read as 
follows:

    Authority: Sec. 512 of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 360b).

    4. Section 520.447 is amended by revising the third sentence in 
paragraph (c)(3) and by adding new paragraph (d) to read as follows:

Sec. 520.447  Clindamycin hydrochloride liquid.

* * * * *
    (c) * * *
    (3) * * * Because of potential adverse gastrointestinal effects, do 
not administer to rabbits, hamsters, guinea pigs, horses, chinchillas, 
or ruminating animals. * * *
    (d) Conditions of use in cats--(1) Amount. 5.0 to 10.0 milligrams 
per pound of body weight every 24 hours for a maximum of 14 days (11 to 
22 milligrams per kilogram of body weight per day).
    (2) Indications for use. Aerobic bacteria: Treatment of soft tissue 
infections (wounds and abscesses) and dental infections caused by or 
associated with susceptible strains of Staphylococcus 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 
Clostridium perfringens and Bacteroides fragilis.
    (3) Limitations. Wound infections, abscesses, and dental 
infections: Do not use for more than 4 days if no improvement of acute 
infection is observed. Because of potential adverse gastrointestinal 
effects, do not administer to rabbits, hamsters, guinea pigs, horses, 
chinchillas, or ruminating animals. Use with caution in animals 
receiving neuromuscular blocking agents, because clindamycin may 
potentiate their action. Prescribe with caution in atopic animals. 
Federal law restricts this drug to use by or on the order of a licensed 
veterinarian.

PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

    5. The authority citation for 21 CFR part 522 continues to read as 
follows:

    Authority: Sec. 512 of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 360b).

Sec. 522.1145  [Amended]

    6. Section 522.1145 Hyaluronate sodium injection is amended in 
paragraph (a)(2) by removing ``000016'' and adding in its place 
``000009''.

    Dated: November 6, 1996.
Robert C. Livingston,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 96-29696 Filed 11-19-96; 8:45 am]
BILLING CODE 4160-01-F