04-13790. Notice of Approval of Abbreviated New Animal Drug Application; Dexamethasone Sodium Phosphate Injection

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration's Center for Veterinary Medicine (CVM) is providing notice that it has approved an original abbreviated new animal drug application (ANADA) filed by Cross Vetpharm Group Ltd. The ANADA provides for the veterinary prescription use of dexamethasone sodium phosphate injectable solution as a rapid adrenal glucocorticoid and/or anti-inflammatory agent in horses. The applicable sections of the regulations did not require amendment.

FOR FURTHER INFORMATION CONTACT:

Lonnie W. Luther, Center for Veterinary Medicine (HFV-104), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 301-827-8549, e-mail: [e-mail].

SUPPLEMENTARY INFORMATION:

In accordance with section 512(i) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360b(i)) and 21 CFR 514.105(a) and 514.106(a), CVM is providing notice that it has approved original ANADA 200-317 filed by Cross Vetpharm Group Ltd., Broomhill Rd., Tallaght, Dublin 24, Ireland. ANADA 200-317 provides for the veterinary prescription use of DEXIUM-SP (dexamethasone sodium phosphate) Injection as a rapid adrenal glucocorticoid and/or anti-inflammatory agent in horses. Cross Vetpharm Group's DEXIUM-SP Injection is approved as a generic copy of Steris Laboratories, Inc.'s Dexamethasone Injection, approved under NADA 104-606. The ANADA is approved as of April 29, 2004. 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 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 Division of Dockets Management (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.

The agency has determined under 21 CFR 25.33(a)(1) 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.

Dated: June 4, 2004.

Stephen F. Sundlof,

Director, Center for Veterinary Medicine.