[Federal Register Volume 60, Number 109 (Wednesday, June 7, 1995)]
[Rules and Regulations]
[Pages 29984-29985]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-13830]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 522


Implantation or Injectable Dosage Form New Animal Drugs; 
Dexamethasone 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 an abbreviated new animal drug 
application (ANADA) filed by Phoenix Pharmaceutical, Inc. The ANADA 
provides for use of dexamethasone injection in cattle for the treatment 
of primary bovine ketosis and in dogs, cats, cattle, and horses as an 
anti-inflammatory agent.

EFFECTIVE DATE: June 7, 1995.

FOR FURTHER INFORMATION CONTACT: Melanie R. Berson, Center for 
Veterinary Medicine (HFV-135), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-594-1643.

SUPPLEMENTARY INFORMATION: Phoenix Pharmaceutical, Inc., 4621 Easton 
Rd., [[Page 29985]] P.O. Box 6457 Farleigh Station, St. Joseph, MO 
64506-0457, has filed ANADA 200-108, which provides for intravenous or 
intramuscular use of Dexamethasone Solution (2 milligrams (mg) of 
dexamethasone per milliliter (mL)) in cattle for the treatment of 
primary bovine ketosis and in dogs, cats, cattle, and horses as an 
anti-inflammatory agent.
    Phoenix Pharmaceutical, Inc.'s, ANADA 200-108 for Dexamethasone 
Solution (2 mg/mL) is approved as a generic copy of Schering-Plough 
Animal Health Corp.'s NADA 12-559 for Azium (dexamethasone 
solution). The ANADA is approved as of April 13, 1995, and the 
regulations are amended in 21 CFR 522.540(a)(2) to reflect the 
approval. The basis for 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, rm. 1-23, 
12420 Parklawn Dr., Rockville, MD 20857, between 9 a.m. and 4 p.m., 
Monday through Friday.
    The agency has carefully considered the potential environmental 
effects of this action. FDA has concluded that the action will not have 
a significant impact on the human environment, and that an 
environmental impact statement is not required. The agency's finding of 
no significant impact and the evidence supporting that finding, 
contained in an environmental assessment, may be seen in the Dockets 
Management Branch (address above) between 9 a.m. and 4 p.m., Monday 
through Friday.

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 522.540 is amended by revising paragraph (a)(2) to read 
as follows:


Sec. 522.540  Dexamethasone injection.

    (a) * * *
    (2) Sponsor. See Nos. 000061 and 057319 in Sec. 510.600(c) of this 
chapter.
* * * * *

    Dated: May 23, 1995.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 95-13830 Filed 6-6-95; 8:45 am]
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