# [Amended]
**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.
**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 protected].*
**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 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.
**List of Subjects**
Administrative practice and procedure, Animal drugs, Labeling, Reporting and recordkeeping requirements.
Animal drugs.
**21 CFR Part 510,520,522,529**
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:
**PART 510-NEW ANIMAL DRUGS**
1. The authority citation for 21 CFR part 510 continues to read as follows:
**Authority:**
21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e.
**21 CFR Part 510**
§ 510.600
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”.
**21 CFR Part 520**
**PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS**
3. The authority citation for 21 CFR part 520 continues to read as follows:
**Authority:**
21 U.S.C. 360b.
**21 CFR Part 520**
§ 520.1720a
4. Section 520.1720a *Phenylbutazone tablets and boluses* is amended in paragraph (b)(3) by removing “000864”.
**21 CFR Part 522**
**PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS**
5. The authority citation for 21 CFR part 522 continues to read as follows:
**Authority:**
21 U.S.C. 360b.
**21 CFR Part 522**
§ 522.480
6. Section 522.480 *Repository corticotropin injection* is amended in paragraph (b)(2) by removing “000864” and by adding in its place “061623”.
**21 CFR Part 522**
§ 522.540
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”.
**21 CFR Part 522**
§ 522.1010
8. Section 522.1010 *Furosemide* is amended in paragraph (b)(2) by removing “000864” and by adding in its place “061623”.
**21 CFR Part 522**
§ 522.1720
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).
**21 CFR Part 522**
10. Section 522.1883 is revised to read as follows:
§ 522.1883
(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.
**21 CFR Part 522**
11. Section 522.1962 is amended:
a. By removing “injection” from the heading;
b. By removing footnote 1;
c. In paragraph (b) by removing “000864” and by adding in its place “061623”;
d. By removing paragraphs (c)(3) and (c)(4);
e. By revising paragraphs (a) and (c)(2); and
f. By adding a heading to (c)(1).
The amendments read as follows:
§ 522.1962
(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.
**21 CFR Part 522**
§ 522.2063
12. Section 522.2063 *Pyrilamine maleate injection* is amended in paragraph (b) by removing “000864” and by adding in its place “061623”.
**21 CFR Part 529**
**PART 529—CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS**
13. The authority citation for 21 CFR part 529 continues to read as follows:
**Authority:**
21 U.S.C. 360b.
**21 CFR Part 529**
§ 529.1044a
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”.
Dated: October 2, 2003.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary Medicine.