Food and Drug Administration, HHS.
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of an original abbreviated new animal drug application (ANADA) filed by Modern Veterinary Therapeutics, LLC. The ANADA provides for use of an injectable solution of butorphanol tartrate in cats for the relief of pain.
This rule is effective April 29, 2010.Start Further Info
FOR FURTHER INFORMATION CONTACT:
John K. Harshman, Center for Veterinary Medicine (HFV-170), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240-276-8197, e-mail: email@example.com.End Further Info End Preamble Start Supplemental Information
Modern Veterinary Therapeutics, LLC, 1550 Madruga Ave., suite 329, Coral Gables, FL 33146, filed ANADA 200-446 for the use of BUTORPHINE (butorphanol tartrate, USP) Veterinary Injection in cats for the relief of pain. Modern Veterinary Therapeutics' BUTORPHINE Veterinary Injection is approved as a generic copy of TORBUGESIC-SA (butorphanol tartrate, USP) Veterinary Injection, approved under NADA 141-047 held by Fort Dodge Animal Health, Division of Wyeth, a wholly owned subsidiary of Pfizer, Inc. The ANADA is approved as of March 26, 2010, and the regulations in 21 CFR 522.246 are amended to reflect the approval.
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.
FDA has determined under 21 CFR 25.33 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.
This rule does not meet the definition of “rule” in 5 U.S.C. 804(3)(A) because it is a rule of “particular applicability.” Therefore, it is not subject to the congressional review requirements in 5 U.S.C. 801-808.Start List of Subjects
List of Subjects in 21 CFR Part 522End List of Subjects Start Amendment Part
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,End Amendment Part Start Part
PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGSEnd Part Start Amendment Part
1. The authority citation forEnd Amendment Part
2. In paragraph (b)(2) of § 522.246, remove “No. 059130” and in its place add “Nos. 015914 and 059130”.End Amendment Part Start Signature
Dated: April 23, 2010.
William T. Flynn,
Acting Director, Center for Veterinary Medicine.
[FR Doc. 2010-9871 Filed 4-28-10; 8:45 am]
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