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