[Federal Register Volume 61, Number 203 (Friday, October 18, 1996)] [Rules and Regulations] [Pages 54332-54333] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 96-26685] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 522 Implantation or Injectable Dosage Form New Animal Drugs; Phenylbutazone Injection
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 abbreviated new animal drug application (ANADA) filed by Phoenix Scientific, Inc. The supplemental ANADA provides for use of phenylbutazone injection in dogs for relief of inflammatory conditions associated with the musculoskeletal system.
EFFECTIVE DATE: October 18, 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
Phoenix Scientific, Inc., 3915 South 48th St. Terrace, P.O. Box 6457, St. Joseph, MO 64506-0457, filed a supplement to ANADA 200-126 which provides for intravenous use of phenylbutazone injection in dogs for relief of inflammatory conditions associated with the musculoskeletal system. The ANADA is currently approved for use of the drug in horses. The drug is limited to use by or on the order of a licensed veterinarian. Approval of supplemental ANADA 200-126 for Phoenix's phenylbutazone injection 20 percent is as a generic copy of Cooper's NADA 11-575 Butazolidin Injectable 20 percent (phenylbutazone). Supplemental ANADA 200-126 is approved as of September 6, 1996, and the regulations are amended by revising Sec. 522.1720(b) (21 CFR 522.1720(b)), 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 part 20 (21 CFR part 20) and Sec. 514.11(e)(2)(ii) (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. The agency has determined under 21 CFR 25.24(d)(1)(i) 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: Sec. 512 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360b).
2. Section 522.1720 is amended by revising paragraphs (b)(1) and (b)(2) to read as follows:
Sec. 522.1720 Phenylbutazone injection.
* * * * * (b) Sponsors. (1) Approval for use of the 200 milligrams per milliliter drug in dogs and horses: See sponsor Nos. 000031, 011716, 015579, and 059130 in Sec. 510.600(c) of this chapter. (2) Approval for use of the 200 milligrams per milliliter drug for use in horses: See sponsor Nos. 000010, 000402, and 000864 in Sec. 510.600(c) of this chapter. * * * * *
Dated: October 4, 1996. Stephen F. Sundlof, Director, Center for Veterinary Medicine. [FR Doc. 96-26685 Filed 10-17-96; 8:45 am] BILLING CODE 4160-01-F