Food and Drug Administration, HHS.
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor for 12 approved new animal drug applications (NADAs) and 1 abbreviated new animal drug application (ANADA) from Anthony Products Co. to Cross Vetpharm Group, Ltd.
This rule is effective October 20, 2003.Start Further Info
FOR FURTHER INFORMATION CONTACT:
David R. Newkirk, Center for Veterinary Medicine (HFV-100), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-827-6967, e-mail: email@example.com.End Further Info End Preamble Start Supplemental Information
Anthony Products Co., 5600 Peck Rd., Arcadia, CA 91006, has informed FDA that it has transferred ownership of, and all rights and interest in, the following 12 approved NADAs and one approved ANADA to Cross Vetpharm Group, Ltd., Broomhill Rd., Tallaght, Dublin 24, Ireland.
|Application No.||21 CFR Section||Trade Name|
|NADA 046-780||522.1720||PHEN-BUTA-VET (phenylbutazone) Injection|
|NADA 096-671||522.1720||PHEN-BUTA-VET (phenylbutazone) Injection|
|NADA 096-672||520.1720a||PHEN-BUTA-VET (phenylbutazone) Tablets|
|NADA 098-288||522.1883||PREDNIS-A-VET (prednisolone sodium phosphate) Injection|
|NADA 099-604||522.540||DEX-A-VET (dexamethasone sodium phosphate) Injection|
|NADA 099-605||522.540||DEX-A-VET (dexamethasone sodium phosphate) Injection|
|NADA 099-606||522.540||DEXAMETH-A-VET (dexamethasone) Injection|
|NADA 099-607||522.540||DEXAMETH-A-VET (dexamethasone) Injection|
|NADA 118-550||522.1010||FUROS-A-VET (furosemide) Injection|
|NADA 119-141||522.1962||TRANQUAZINE (promazine hydrochloride) Injection|
|NADA 138-405||522.2063||Pyrilamine Maleate Injection|
|NADA 140-583||522.480||ACTH Gel|
|ANADA 200-115||529.1044a||GENTAMEX 100 (gentamicin sulfate)|
Accordingly, the agency is amending the regulations in 21 CFR 520.1720a, 522.480, 522.540, 522.1010, 522.1720, 522.1883, 522.1962, 522.2063, and 529.1044a to reflect the transfer of ownership. Sections 522.1883 and 522.1962 are also being revised to reflect a current format.
Following these changes of sponsorship, Anthony Products Co. is no longer the sponsor of an approved application. Accordingly, § 510.600(c) is being amended to remove the entries for Anthony Products Co.
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
- Administrative practice and procedure
- Animal drugs
- Reporting and recordkeeping requirements
, 522, and 529End 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 510-NEW ANIMAL DRUGSEnd Part Start Amendment Part
1. The authority citation forEnd Amendment Part
2. Section 510.600End Amendment Part Start Part
PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGSEnd Part Start Amendment Part
3. The authority citation forEnd Amendment Part
4. Section 520.1720aEnd Amendment Part Start Part
PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGSEnd Part Start Amendment Part
5. The authority citation forEnd Amendment Part
6. Section 522.480End Amendment Part
7. Section 522.540End Amendment Part
8. Section 522.1010End Amendment Part
9. Section 522.1720End Amendment Part Start Amendment Part
10. Section 522.1883 is revised to read as follows:End Amendment Part
(a) Specifications. Each milliliter of solution contains 20 milligrams (mg) prednisolone sodium phosphate (equivalent to 14.88 mg of prednisolone).
(b) Sponsor. See No. 061623 in § 510.600(c) of this chapter.
(c) Conditions of use in dogs—(1) Amount. Administer intravenously in a dosage of 2 1/2 to 5 mg per pound of body weight, initially for shock and shock-like states, followed by equal maintenance doses at 1-, 3-, 6-, or 10-hour intervals as determined by the condition of the animal.
(2) Indications for use. Administer when a rapid adrenal glucocorticoid and/or anti-inflammatory effect is necessary.
(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.Start Amendment Part
11. Section 522.1962 is amended:End Amendment Part Start Amendment Part
a. By removing “injection” from the heading;End Amendment Part Start Amendment Part
b. By removing footnote 1;End Amendment Part Start Amendment Part
c. In paragraph (b) by removing “000864” and by adding in its place “061623”;End Amendment Part Start Amendment Part
d. By removing paragraphs (c)(3) and (c)(4);End Amendment Part Start Amendment Part
e. By revising paragraphs (a) and (c)(2); andEnd Amendment Part Start Amendment Part
f. By adding a heading to (c)(1).End Amendment Part Start Amendment Part
The amendments read as follows:End Amendment Part
(a) Specifications. Each milliliter of solution contains 50 milligrams (mg) promazine hydrochloride.
(c) * * *
(1) Amounts and indications for use. (i) * * *
(2) Limitations. Not for use in horses intended for food. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
12. Section 522.2063End Amendment Part Start Part
PART 529—CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGSEnd Part Start Amendment Part
13. The authority citation forEnd Amendment Part
14. Section 529.1044aEnd Amendment Part Start Signature
Dated: October 2, 2003.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary Medicine.
[FR Doc. 03-26336 Filed 10-17-03; 8:45 am]
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