[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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