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Rule

New Animal Drugs; Change of Sponsor

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Information about this document as published in the Federal Register.

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AGENCY:

Food and Drug Administration, HHS.

ACTION:

Final rule.

SUMMARY:

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.

DATES:

This rule is effective October 20, 2003.

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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: dnewkirk@cvm.fda.gov.

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SUPPLEMENTARY 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 SectionTrade Name
NADA 046-780522.1720PHEN-BUTA-VET (phenylbutazone) Injection
NADA 096-671522.1720PHEN-BUTA-VET (phenylbutazone) Injection
NADA 096-672520.1720aPHEN-BUTA-VET (phenylbutazone) Tablets
NADA 098-288522.1883PREDNIS-A-VET (prednisolone sodium phosphate) Injection
NADA 099-604522.540DEX-A-VET (dexamethasone sodium phosphate) Injection
NADA 099-605522.540DEX-A-VET (dexamethasone sodium phosphate) Injection
NADA 099-606522.540DEXAMETH-A-VET (dexamethasone) Injection
NADA 099-607522.540DEXAMETH-A-VET (dexamethasone) Injection
NADA 118-550522.1010FUROS-A-VET (furosemide) Injection
NADA 119-141522.1962TRANQUAZINE (promazine hydrochloride) Injection
NADA 138-405522.2063Pyrilamine Maleate Injection
NADA 140-583522.480ACTH Gel
ANADA 200-115529.1044aGENTAMEX 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.

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List of Subjects

21 CFR Part 510

  • Administrative practice and procedure
  • Animal drugs
  • Labeling
  • Reporting and recordkeeping requirements

21 CFR Parts 520, 522, and 529

  • Animal drugs
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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 parts 510, 520, 522, and 529 are amended as follows:

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PART 510-NEW ANIMAL DRUGS

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1. The authority citation for 21 CFR part 510 continues to read as follows:

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Authority: 21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e.

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[Amended]
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2. Section 510.600 Names, addresses, and drug labeler codes of sponsors of approved applications is amended in the table in paragraph (c)(1) by removing the entry for “Anthony Products Co.” and in the table in paragraph (c)(2) by removing the entry for “000864”.

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PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS

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3. The authority citation for 21 CFR part 520 continues to read as follows:

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Authority: 21 U.S.C. 360b.

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[Amended]
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4. Section 520.1720a Phenylbutazone tablets and boluses is amended in paragraph (b)(3) by removing “000864”.

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PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

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5. The authority citation for 21 CFR part 522 continues to read as follows:

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Authority: 21 U.S.C. 360b.

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[Amended]
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6. Section 522.480 Repository corticotropin injection is amended in paragraph (b)(2) by removing “000864” and by adding in its place “061623”.

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[Amended]
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7. Section 522.540 Dexamethasone injection is amended in paragraphs (b)(2)(i) and (c)(2) by removing “000864” and by adding in its place “061623”.

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[Amended]
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8. Section 522.1010 Furosemide is amended in paragraph (b)(2) by removing “000864” and by adding in its place “061623”.

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[Amended]
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9. Section 522.1720 Phenylbutazone injection is amended in paragraph (b)(1) by removing “and 059130” and by adding in its place “059130, and 061623”; in paragraph (b)(2) by removing “Nos. 000010 and 000864” and by adding in its place “No. 000010”; and by removing paragraph (b)(4).

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10. Section 522.1883 is revised to read as follows:

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Prednisolone sodium phosphate.

(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.

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11. Section 522.1962 is amended:

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a. By removing “injection” from the heading;

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b. By removing footnote 1;

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c. In paragraph (b) by removing “000864” and by adding in its place “061623”;

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d. By removing paragraphs (c)(3) and (c)(4);

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e. By revising paragraphs (a) and (c)(2); and

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f. By adding a heading to (c)(1).

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The amendments read as follows:

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Promazine hydrochloride.

(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.

[Amended]
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12. Section 522.2063 Pyrilamine maleate injection is amended in paragraph (b) by removing “000864” and by adding in its place “061623”.

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PART 529—CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS

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13. The authority citation for 21 CFR part 529 continues to read as follows:

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Authority: 21 U.S.C. 360b.

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[Amended]
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14. Section 529.1044a Gentamicin sulfate intrauterine solution is amended in paragraph (b) by removing “000864, 057561, and 059130” and by adding in its place “057561, 059130, and 061623”.

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Dated: October 2, 2003.

Steven D. Vaughn,

Director, Office of New Animal Drug Evaluation, Center for Veterinary Medicine.

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[FR Doc. 03-26336 Filed 10-17-03; 8:45 am]

BILLING CODE 4160-01-S