Animal drugs, feeds, and related products: New drug applications— Florfenicol solution,

[Federal Register: February 4, 1999 (Volume 64, Number 23)]

[Rules and Regulations]

[Page 5595-5596]

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

[DOCID:fr04fe99-6]

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 522

Implantation or Injectable Dosage Form New Animal Drugs; Florfenicol Solution

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 supplemental new animal drug application (NADA) filedby Schering-Plough Animal Health Corp. The supplemental NADA provides for subcutaneous use of florfenicol injectable solution for control of respiratory disease in cattle at high risk of developing bovine respiratory disease (BRD).

EFFECTIVE DATE: February 4, 1999.

FOR FURTHER INFORMATION CONTACT: William T. Flynn, Center for Veterinary Medicine (HFV-133), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-827-7570.

SUPPLEMENTARY INFORMATION: Schering-Plough Animal Health Corp., 1095 Morris Ave., P.O. Box 1982, Union, NJ

[[Page 5596]]

07083-1982, is sponsor of NADA 141-063 that provides for veterinary prescription use of Nuflor‹Register› Injectable Solution (florfenicol) for treatment of cattle for BRD. The firm fileda supplemental NADA that provides for veterinary prescription use of Nuflor‹Register› Injectable Solution (florfenicol) by a single subcutaneous injection for control of respiratory disease in cattle at high risk of developing BRD associated with Pasteurella haemolytica, P. multocida, and Haemophilus somnus. The supplemental NADA is approved as of December 17, 1998, and the regulations are amended by revising 21 CFR 522.955(d)(1) to reflect the approval. The 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 supplement 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 21 U.S.C. 360b(c)(2)(F)(iii), this supplemental approval for food-producing animals qualifies for 3 years of marketing exclusivity beginning December 17, 1998, because the supplemental application contains substantial evidence of the effectiveness of the drug involved, any studies of animal safety or, in the case of food- producing animals, human food safety studies (other than bioequivalence or residue studies) required for approval and conducted or sponsored by the applicant. Three years marketing exclusivity is limited to subcutaneous use of the drug for control of respiratory disease in cattle at high risk of developing BRD associated with P. haemolytica, P. multocida, and H. somnus.

The agency has determined under 21 CFR 25.33(d)(5) 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 in 21 CFR Part 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 part 522 is amended as follows:

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

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

   Authority: 21 U.S.C. 360b.

2. Section 522.955 is amended by revising paragraph (d)(1)(i), by redesignating paragraph (d)(1)(ii) as paragraph (d)(1)(i)(B), and by adding paragraphs (d)(1)(ii)(A) and (d)(1)(ii)(B) to read as follows:

   Sec. 522.955 Florfenicol solution.

   * * * * *

   (d) * * *

   (1) * * *

   (i) Treatment of disease--(A) Amount. 20 milligrams per kilogram of body weight (3 milliliters per 100 pounds) as an intramuscular injection. A second dose should be given 48 hours later. Alternatively, 40 milligrams per kilogram of body weight (6 milliliters per 100 pounds) as a single subcutaneous injection may be used.

   (B) Indications for use. * * *

   (ii) Control of disease--(A) Amount. 40 milligrams per kilogram of body weight (6 milliliters per 100 pounds) as a single subcutaneous injection.

   (B) Indications for use. For control of respiratory disease in cattle at high risk of developing bovine respiratory disease (BRD) associated with Pasteurella haemolytica, P. multocida, and Haemophilus somnus. * * * * *

   Dated: January 13, 1999. Andrew J. Beaulieu, Acting Director, Office of New Animal Drug Evaluation, Center for Veterinary Medicine.

   [FR Doc. 99-2686Filed2-3-99; 8:45 am]

   BILLING CODE 4160-01-F