[Federal Register Volume 59, Number 205 (Tuesday, October 25, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-26453]


[[Page Unknown]]

[Federal Register: October 25, 1994]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Parts 520 and 522

 

Animal Drugs, Feeds, and Related Products; Change of Sponsor

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 a change of sponsor name and address for 
two new animal drug applications (NADA's) from Sanofi Animal Health, 
Inc. to Wendt Laboratories, Inc.

EFFECTIVE DATE: October 25, 1994.

FOR FURTHER INFORMATION CONTACT: Benjamin A. Puyot, Center for 
Veterinary Medicine (HFV-130), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-594-1646.

SUPPLEMENTARY INFORMATION: Sanofi Animal Health, Inc., 7107 College 
Blvd., suite 610, Overland Park, KS 66210, has informed FDA that it has 
transferred ownership of, and all rights and interests in, approved 
NADA's 48-646 (Phenylbutazone Injection) and 48-647 (Phenylbutazone 
Tablets) to Wendt Laboratories, Inc., 100 Nancy Dr., Belle Plaine, MN 
56011. Accordingly, the agency is amending the regulations in 21 CFR 
520.1720a(b)(3) and 21 CFR 522.1720(b)(1) to reflect the change of 
sponsor.

List of Subjects

21 CFR Part 520

    Animal drugs.

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 parts 520 and 
522 are 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: Sec. 512 of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 360b).

Sec. 520.1720a  [Amended]

    2. Section 520.1720a Phenylbutazone tablets and boluses is amended 
in paragraph (b)(3) by removing ``050604'' and adding in its place 
``015579''.

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

    3. The authority citation of 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. 522.1720  [Amended]

    4. Section 522.1720 Phenylbutazone injection is amended in 
paragraph (b)(1) by removing ``050604'' and adding in its place 
``015579''.

    Dated: October 14, 1994.
Robert C. Livingston,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 94-26453 Filed 10-24-94; 8:45 am]
BILLING CODE 4160-01-F