[Federal Register Volume 62, Number 223 (Wednesday, November 19, 1997)]
[Rules and Regulations]
[Pages 61626-61627]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-30411]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510 and 520


Oral Dosage Form New Animal Drugs; Orbifloxacin Tablets

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 Schering-Plough Animal Health. The 
supplemental NADA provides for veterinary prescription use of 
orbifloxacin tablets for management of diseases in cats associated with 
bacteria susceptible to orbifloxacin.

EFFECTIVE DATE: November 19, 1997.
FOR FURTHER INFORMATION CONTACT:  Joseph J. Bertone, Center for 
Veterinary Medicine (HFV-114), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-594-1692.

SUPPLEMENTARY INFORMATION: Schering-Plough Animal Health Corp., 1095 
Morris Ave., Union, NJ 07083, is sponsor of NADA 141-081 
OrbaxTM (orbifloxacin) tablets that provide for veterinary 
prescription use in dogs for management of diseases associated with 
bacteria susceptible to orbifloxacin. The sponsor filed a supplemental 
NADA providing for veterinary prescription use of orbifloxacin tablets 
for management of diseases in cats associated with bacteria susceptible 
to orbifloxacin. The supplemental NADA is approved as of September 18, 
1997, and the regulations are amended in 21 CFR 520.1616 to reflect the 
approval. The basis of approval is discussed in the freedom of 
information summary.
    Furthermore, certain limitations, although required in the 
labeling, are not required in the regulation. Those limitations are 
removed from the regulation at this time.
    Also, the sponsor's address has been changed. At this time, the 
address in the list of sponsors of approved applications in 21 CFR 
510.600(c)(1) and (c)(2) is amended to reflect the new address.
    In accordance with the freedom of information provisions of 21 CFR 
part 20 and 514.11(e)(2)(ii), a summary of safety and effectiveness 
data and information submitted to support approval of this supplemental 
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)), this supplemental approval 
qualifies for 3 years of marketing exclusivity beginning September 18, 
1997, because the supplemental application contains substantial 
evidence of the effectiveness of the drug involved or studies of target 
animal safety required for approval and conducted or sponsored by the 
applicant. Three years marketing exclusivity is limited to use of 
orbifloxacin tablets for cats.
    FDA has determined under 21 CFR 25.33(a)(1) that this action is of 
a type that does not individually or cumulatively have a significant 
effect on the human environment. Therefore, neither an environmental 
assessment nor an environmental impact statement is required.

List of Subjects

 21 CFR Part 510

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

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 parts 510 and 
520 are amended as follows:

PART 510--NEW ANIMAL DRUGS

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

    Authority: 21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e.


Sec. 510.600  [Amended]

    2. Section 510.600 Names, addresses, and drug labeler codes of 
sponsors of approved applications is amended in paragraph (c)(1) in the 
entry for

[[Page 61627]]

``Schering-Plough Animal Health'' and in paragraph (c)(2) in the entry 
for ``000061'' by removing the current address and adding in its place 
the address ``1095 Morris Ave., Union, NJ 07083''.

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.


Sec. 520.1616  [Amended]

    2. Section 520.1616 Orbifloxacin tablets is amended in the heading 
of paragraph (d)(1) and in paragraph (d)(1)(iii) by adding after the 
word ``dogs'' the phrase ``and cats'', and in paragraph (d)(1)(iii) by 
removing the phrase ``2.5 milligrams per kilogram of body weight'' and 
the second, third, and fourth sentences.

    Dated: October 22, 1997.
 Stephen F. Sundlof,
 Director, Center for Veterinary Medicine.
[FR Doc. 97-30411 Filed 11-18-97; 8:45 am]
BILLING CODE 4160-01-F