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Start Preamble
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.
Start Further InfoFOR 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.
End Further Info End Preamble Start Supplemental InformationSUPPLEMENTARY 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 SubjectsList 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
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:
End Amendment Part Start PartPART 510-NEW ANIMAL DRUGS
End Part Start Amendment Part1. The authority citation for 21 CFR part 510 continues to read as follows:
End Amendment Part Start Amendment Part2. 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”.
End Amendment Part Start PartPART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS
End Part Start Amendment Part3. The authority citation for 21 CFR part 520 continues to read as follows:
End Amendment PartStart Amendment Part[Amended]4. Section 520.1720a Phenylbutazone tablets and boluses is amended in paragraph (b)(3) by removing “000864”.
End Amendment Part Start PartPART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
End Part Start Amendment Part5. The authority citation for 21 CFR part 522 continues to read as follows:
End Amendment PartStart Amendment Part[Amended]6. Section 522.480 Repository corticotropin injection is amended in paragraph (b)(2) by removing “000864” and by adding in its place “061623”.
End Amendment PartStart Amendment Part[Amended]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”.
End Amendment PartStart Amendment Part[Amended]8. Section 522.1010 Furosemide is amended in paragraph (b)(2) by removing “000864” and by adding in its place “061623”.
End Amendment PartStart Amendment Part[Amended]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).
End Amendment Part Start Amendment Part10. Section 522.1883 is revised to read as follows:
End Amendment PartPrednisolone 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.
Start Amendment Part11. Section 522.1962 is amended:
End Amendment Part Start Amendment Parta. By removing “injection” from the heading;
End Amendment Part Start Amendment Partb. By removing footnote 1;
End Amendment Part Start Amendment Partc. In paragraph (b) by removing “000864” and by adding in its place “061623”;
End Amendment Part Start Amendment Partd. By removing paragraphs (c)(3) and (c)(4);
End Amendment Part Start Amendment Parte. By revising paragraphs (a) and (c)(2); and
End Amendment Part Start Amendment Partf. By adding a heading to (c)(1).
End Amendment Part Start Amendment PartThe amendments read as follows:
End Amendment PartPromazine 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.
Start Amendment Part[Amended]12. Section 522.2063 Pyrilamine maleate injection is amended in paragraph (b) by removing “000864” and by adding in its place “061623”.
End Amendment Part Start PartPART 529—CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS
End Part Start Amendment Part13. The authority citation for 21 CFR part 529 continues to read as follows:
End Amendment PartStart Amendment Part[Amended]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”.
End Amendment Part Start SignatureEnd Signature End Supplemental InformationDated: 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]
BILLING CODE 4160-01-S
Document Information
- Effective Date:
- 10/20/2003
- Published:
- 10/20/2003
- Department:
- Food and Drug Administration
- Entry Type:
- Rule
- Action:
- Final rule.
- Document Number:
- 03-26336
- Dates:
- This rule is effective October 20, 2003.
- Pages:
- 59880-59881 (2 pages)
- PDF File:
- 03-26336.pdf
- CFR: (10)
- 21 CFR 510.600
- 21 CFR 522.480
- 21 CFR 522.540
- 21 CFR 522.1010
- 21 CFR 522.1720
- More ...