Animal drugs, feeds, and related products: Marbofloxacin tablets,

[Federal Register: July 23, 1999 (Volume 64, Number 141)]

[Rules and Regulations]

[Page 39918-39919]

From the Federal Register Online via GPO Access [wais.access.gpo.gov]

[DOCID:fr23jy99-6]

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 520

Oral Dosage Form New Animal Drugs; Marbofloxacin Tablets

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 a new animal drug application (NADA) filedby Pfizer, Inc. The NADA provides for use of marbofloxacin tablets in dogs for the treatment of infections associated with bacteria susceptible to marbofloxacin.

EFFECTIVE DATE: July 23, 1999.

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.

SUPPLEMENTARY INFORMATION: Pfizer, Inc., 235 East 42d St., New York, NY 10017, filedNADA 141-151 Zeniquin‹SUP›TM‹/SUP› (marbofloxacin) tablets for the treatment of infections in dogs associated with bacteria susceptible to marbofloxacin. The drug is limited to use by or on the order of a licensed veterinarian, and prohibited from extralabel use in food-producing animals. The NADA is approved as of June 26, 1999, and the regulations are amended by adding Sec. 520.1310 to reflect the approval. The

[[Page 39919]]

basis of approval is discussed in the freedom of information summary.

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 application 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.

Under section 512(c)(2)(F)(i) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360b(c)(2)(F)(i)), this approval qualifies for 5 years of marketing exclusivity beginning June 26, 1999, because no active ingredient (including any ester or salt of the active ingredient) has been approved in any other application filedunder section 512(b)(1) of the act.

The agency has determined under 21 CFR 25.33(d)(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.

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 Subjects 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 520.1310 is added to read as follows:

   Sec. 520.1310 Marbofloxacin tablets.

   (a) Specifications. Each tablet contains either 25, 50, 100, or 200 milligrams of marbofloxacin.

   (b) Sponsor. See No. 000069 in Sec. 510.600(c) of this chapter.

   (c) [Reserved]

   (d) Conditions of use--(1) Dogs--(i) Amount. 1.25 milligrams per pound of body weight once daily, but may be increased to 2.5 milligrams per pound of body weight once daily.

   (ii) Indications for use. For the treatment of infections in dogs associated with bacteria susceptible to marbofloxacin.

   (iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Federal law prohibits the extralabel use of this drug in food-producing animals.

   Dated: July 15, 1999. George A. Mitchell, Acting Director, Center for Veterinary Medicine.

   [FR Doc. 99-18769Filed7-22-99; 8:45 am]

   BILLING CODE 4160-01-F