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New Animal Drugs; Changes of Sponsor

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Start Preamble Start Printed Page 17595

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 21 approved new animal drug applications (NADAs) and 43 approved abbreviated new animal drug applications (ANADAs) from Teva Animal Health, Inc., to Bayer HealthCare LLC.

DATES:

This rule is effective March 22, 2013.

Start Further Info

FOR FURTHER INFORMATION CONTACT:

Steven D. Vaughn, Center for Veterinary Medicine (HFV-100), Food and Drug Administration, 7520 Standish Pl., Rockville, MD 20855; 240-276-8300; email: steven.vaughn@fda.hhs.gov.

End Further Info End Preamble Start Supplemental Information

SUPPLEMENTARY INFORMATION:

Teva Animal Health, Inc., 3915 South 48th Street Ter., St. Joseph, MO 64503 has informed FDA that it has transferred ownership of, and all rights and interest in, the following 21 approved NADAs and 43 approved ANADAs to Bayer HealthCare LLC, Animal Health Division, P.O. Box 390, Shawnee Mission, KS 66201:

Table 1—Applications Transferred

Application No.Trade name
6-391S.Q. (sulfaquinoxaline) 40% Type A Medicated Article.
6-677S.Q. (sulfaquinoxaline) 20% Solution.
7-087Sulfaquinoxaline Solubilized.
33-157SPECTAM (spectinomycin) Scour Halt.
40-040SPECTAM (spectinomycin) Injectable Solution.
45-416TEVCODYNE (phenylbutazone) Injectable Solution.
48-287Oxytetracycline-50 Injectable Solution.
55-002TEVCOCIN (chloramphenicol) Injection.
65-110PEN-G-MAX (penicillin G procaine) Injectable Suspension.
65-498DUAL-CILLIN (penicillin G benzathine and penicillin G procaine).
91-818Phenylbutazone Tablets, USP 1 gram.
93-483SPECTAM (spectinomycin) Injectable Solution.
94-170Phenylbutazone Tablets, USP 100 or 200 mg.
99-169Oxytocin Injection.
119-142PVL Iron Dextran Injectable (iron hydrogenated dextran injection).
123-815Dexamethasone Sodium Phosphate Injection.
124-241PVL (oxytocin) Injectable.
128-089ZONOMETH (dexamethasone) Solution.
140-270SULFASURE (sulfamethazine) SR Cattle Bolus.
141-070RAPINOVET (propofol) Injectable Emulsion.
141-245TRIBUTAME (embutramide, chloroquine, and lidocaine) Euthanasia Solution.
200-042Ketamine Hydrochloride Injection, USP.
200-068Oxytetracycline Hydrochloride Injection 100.
200-069FERTELIN (gonadorelin diacetate tetrahydrate) Injection.
200-108Dexamethasone Solution.
200-118Neomycin Oral Solution.
200-123MAXIM-200 (oxytetracycline hydrochloride) Injection.
200-124Flunixin Meglumine Injection.
200-126Phenylbutazone 20% Injection.
200-137Gentamicin Sulfate Solution (IU).
200-147Gentamicin Sulfate Injection.
200-153NEO 200 (neomycin sulfate) Oral Solution.
200-162Tripelennamine Hydrochloride Injection.
200-174Gentamicin Sulfate Pig Pump Oral Solution.
200-177Sulfadimethoxine Injection 40%.
200-178Amikacin Sulfate Injection.
200-181Amikacin Sulfate Solution.
200-192Sulfadimethoxine 12.5% Oral Solution.
200-193Clindamycin Hydrochloride Oral Liquid.
200-202PHOENECTIN (ivermectin) Oral Solution.
200-219Ivermectin Pour-On for Cattle.
200-228PHOENECTIN (ivermectin) Injectable Solution.
200-230Guaifenesin Injection.
200-246Pyrantel Pamoate Oral Suspension (OTC and Rx).
200-248Pyrantel Pamoate Oral Suspension.
200-253PROSTAMATE (dinoprost tromethamine) Injectable Solution.
200-254Iron Dextran Injection—100.
200-256Iron Dextran Injection—200.
200-265Praziquantel Tablets (OTC and Rx).
200-286PHOENECTIN (ivermectin) Paste 1.87%.
200-287GBC (gentamicin sulfate, betamethasone valerate, and clotrimazole) Ointment.
200-293Furosemide Injection 5%.
200-297Ivermectin Chewable Tablets.
200-298Clindamycin Hydrochloride Capsules.
200-319Acepromazine Maleate Injection.
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200-322Butorphanol Tartrate Injection.
200-342Pyrantel Pamoate Paste.
200-351Lincomycin Injectable, USP.
200-360TIAGARD (tiamulin) Liquid Concentrate.
200-365ROBINUL-V (glycopyrrolate) Injectable.
200-382Furosemide Syrup 1%.
200-389Amprolium 9.6% Oral Solution.
200-408Butorphanol Tartrate Injection.
200-463Amprolium-P 9.6% Oral Solution.

Accordingly, the Agency is amending the regulations in 21 CFR parts 510, 520, 522, 524, 529, and 558 to reflect these transfers of ownership. Following these changes of sponsorship, Teva Animal Health, Inc., is no longer the sponsor of an approved application. As such, 21 CFR 510.600 is being amended to remove the entries for this firm.

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

21 CFR Part 510

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

21 CFR Parts 520, 522, 524, and 529

  • Animal drugs

21 CFR Part 558

  • Animal drugs
  • Animal feeds
End List of Subjects

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, 524, 529, and 558 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. In § 510.600, in the table in paragraph (c)(1), remove the entry for “Teva Animal Health, Inc.”; and in the table in paragraph (c)(2), remove the entry for “059130”.

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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]
Start Amendment Part

4. In paragraph (b)(3) of § 520.100, remove “059130” and in its place add “000859”.

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[Amended]
Start Amendment Part

5. In paragraph (b)(1) of § 520.446, remove “059130” and in its place add “000859”.

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[Amended]
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6. In paragraph (b) of § 520.447, remove “000009, 051311, 058829, and 059130” and in its place add “000009, 000859, 051311, and 058829”.

End Amendment Part
[Amended]
Start Amendment Part

7. In paragraph (b)(3) of § 520.1010, remove “058829 and 059130” and in its place add “000859 and 058829”.

End Amendment Part
[Amended]
Start Amendment Part

8. In paragraph (b) of § 520.1044b, remove “059130” and in its place add “000859”.

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[Amended]
Start Amendment Part

9. In paragraph (b)(2) of § 520.1192, remove “051311, 054925, 059130, and 061623” and in its place add “000859, 051311, 054925, and 061623”.

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[Amended]
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10. In paragraph (b)(2) of § 520.1193, remove “051311 and 059130” and in its place add “000859 and 051311”.

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[Amended]
Start Amendment Part

11. In paragraph (b)(1) of § 520.1195, remove “050604, 054925, and 059130” and in its place add “000859, 050604, and 054925”.

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[Amended]
Start Amendment Part

12. In paragraph (b)(3) of § 520.1484, remove “000009, 054925, 058005, and 059130” and in its place add “000009, 000859, 054925, and 058005”.

End Amendment Part
[Amended]
Start Amendment Part

13. In paragraph (b)(2) of § 520.1720a, remove “059130” and in its place add “000859”.

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[Amended]
Start Amendment Part

14. In paragraph (b)(2) of § 520.1870, remove “059130” and in its place add “000859”.

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[Amended]
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15. In paragraph (b)(1) of § 520.2043, remove “000069, 058829, and 059130” and in its place add ” 000069, 000859, and 058829”.

End Amendment Part
[Amended]
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16. In paragraph (b)(2) of § 520.2044, remove “059130” and in its place add “000859”.

End Amendment Part
[Amended]
Start Amendment Part

17. In paragraph (b) of § 520.2123c, remove “059130” and in its place add “000859”.

End Amendment Part
[Amended]
Start Amendment Part

18. In paragraph (a)(1) of § 520.2220a, remove “000010, 000069, 054925, 057561, and 059130” and in its place add “000010, 000069, 000859, 054925, and 057561”.

End Amendment Part
[Amended]
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19. In paragraph (f)(1) of § 520.2260b, remove “059130” and in its place add “000859”.

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[Amended]
Start Amendment Part

20. In paragraph (a)(1) of § 520.2325a, remove “059130” and in its place add “000859”.

End Amendment Part Start Amendment Part

21. In § 520.2455, revise paragraph (b)(2) and add paragraph (b)(3) to read as follows:

End Amendment Part
Tiamulin.
* * * * *

(b) * * *

(2) No. 066104 for the product described in paragraph (a)(1) of this section.

(3) No. 000859 for the product described in paragraph (a)(3) of this section.

* * * * *
Start Part Start Printed Page 17597

PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

End Part Start Amendment Part

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

End Amendment Part Start Authority

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

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[Amended]
Start Amendment Part

23. In paragraph (b)(2) of § 522.23, remove “059130” and in its place add “000859”.

End Amendment Part
[Amended]
Start Amendment Part

24. In paragraph (b) of § 522.56, remove “059130” and in its place add “000859”.

End Amendment Part
[Amended]
Start Amendment Part

25. In § 522.246, in paragraphs (b)(2) and (b)(3), remove “059130” and in its place add “000859”.

End Amendment Part
[Amended]
Start Amendment Part

26. In paragraph (b) of § 522.390, remove “059130” and in its place add “000859”.

End Amendment Part
[Amended]
Start Amendment Part

27. In § 522.540, in paragraphs (a)(2)(i), (d)(2)(i), and (e)(2), remove “059130” and in its place add “000859”; in paragraphs (b)(3)(i), (b)(3)(ii), (c)(3)(i), and (c)(3)(ii), remove the footnote reference “1”; and remove the text of footnote 1.

End Amendment Part
[Amended]
Start Amendment Part

28. In paragraph (b) of § 522.810, remove “059130” and in its place add “000859”.

End Amendment Part
[Amended]
Start Amendment Part

29. In paragraph (b)(3) of § 522.1010, remove “059130” and in its place add “000859”.

End Amendment Part
[Amended]
Start Amendment Part

30. In paragraph (b)(4) of § 522.1044, remove “059130” and in its place add “000859”.

End Amendment Part
[Amended]
Start Amendment Part

31. In paragraph (b) of § 522.1066, remove “059130” and in its place add “000859”.

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[Amended]
Start Amendment Part

32. In paragraph (b) of § 522.1086, remove “037990 and 059130” and in its place add “000859 and 037990”.

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[Amended]
Start Amendment Part

33. In § 522.1182, in paragraph (b)(1), remove “042552 and 059130” and in its place add “000859 and 042552”; in paragraph (b)(6), remove “058005 and 059130” and in its place add “000859 and 058005”; and in paragraph (b)(7), remove “042552 and 059130” and in its place add “000859 and 042552”.

End Amendment Part
[Amended]
Start Amendment Part

34. In paragraph (b)(2) of § 522.1192, remove “055529, 058005, 059130, and 061623” and in its place add “000859 055529, 058005, and 061623”.

End Amendment Part
[Amended]
Start Amendment Part

35. In paragraph (b) of § 522.1222a, remove “059130” and in its place add “000859”.

End Amendment Part
[Amended]
Start Amendment Part

36. In paragraph (b)(2) of § 522.1260, remove “058005 and 059130” and in its place add “000859 and 058005”.

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[Amended]
Start Amendment Part

37. In paragraph (b) of § 522.1660a, remove “000010, 000069, 048164, 055529, 057561, 059130, and 061623” and in its place add “000010, 000069, 000859, 048164, 055529, 057561, and 061623”.

End Amendment Part
[Amended]
Start Amendment Part

38. In paragraph (i)(2) of § 522.1662a, remove “059130” and in its place add “000859”.

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[Amended]
Start Amendment Part

39. In paragraph (b) of § 522.1680, remove “000010, 000856, 059130, 059130, and 061623” and in its place add “000010, 000856, 000859, and 061623”.

End Amendment Part
[Amended]
Start Amendment Part

40. In paragraph (b)(2) of § 522.1696a, remove “055529, 059130, and 061623” and in its place add “000859, 055529, and 061623”.

End Amendment Part
[Amended]
Start Amendment Part

41. In § 520.1696b:

End Amendment Part Start Amendment Part

a. In paragraph (b)(1), remove “053501, 055529, and 059130” and in its place add “000859, 053501, and 055529”.

End Amendment Part Start Amendment Part

b. In paragraph (d)(2)(i)(A), remove “053501, 055529, 059130, and 061623” and in its place add “000859, 053501, 055529, and 061623”.

End Amendment Part Start Amendment Part

c. In paragraph (d)(2)(iii)(B), remove “055529 and 059130” and in its place add “000859 and 055529”.

End Amendment Part
[Amended]
Start Amendment Part

42. In paragraph (b)(1) of § 522.1720, remove “059130” and in its place add “000859”.

End Amendment Part
[Amended]
Start Amendment Part

43. In paragraph (b)(1) of § 522.2005, remove “059130” and in its place add “000859”.

End Amendment Part
[Amended]
Start Amendment Part

44. In paragraph (b) of § 522.2120, remove “059130” and in its place add “000859”.

End Amendment Part
2220 [Amended]
Start Amendment Part

45. In paragraph (a)(2)(iii) of § 522.2220, remove “059130” and in its place add “000859”.

End Amendment Part
[Amended]
Start Amendment Part

46. In paragraph (b) of § 522.2615, remove “053501 and 059130” and in its place add “000859 and 053501”.

End Amendment Part Start Part

PART 524—OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS

End Part Start Amendment Part

47. The authority citation for 21 CFR part 524 continues to read as follows:

End Amendment Part Start Authority

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

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[Amended]
Start Amendment Part

48. In paragraph (b)(3) of § 524.1044g, remove “059130” and in its place add “000859”.

End Amendment Part
[Amended]
Start Amendment Part

49. In paragraph (b)(2) of § 524.1193, remove “054925, 059130, and 066916” and in its place add “000859, 054925, and 066916”.

End Amendment Part Start Part

PART 529—CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS

End Part Start Amendment Part

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

End Amendment Part Start Authority

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

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[Amended]
Start Amendment Part

51. In paragraph (b) of § 529.56, remove “059130” and in its place add “000859”.

End Amendment Part
[Amended]
Start Amendment Part

52. In paragraph (b) of § 529.1044a, remove “000010, 000061, 000856, 057561, 058005, 059130, and 061623” and in its place add “000010, 000061, 000856, 000859, 057561, 058005, and 061623”.

End Amendment Part Start Part

PART 558—NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS

End Part Start Amendment Part

53. The authority citation for 21 CFR part 558 continues to read as follows:

End Amendment Part Start Authority

Authority: 21 U.S.C. 360b, 371.

End Authority
[Amended]
Start Amendment Part

54. In paragraph (b) of § 558.586, remove “059130” and in its place add “000859”.

End Amendment Part Start Signature
Start Printed Page 17598

Dated: March 12, 2013.

Steven D. Vaughn,

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

End Signature End Supplemental Information

[FR Doc. 2013-06126 Filed 3-21-13; 8:45 am]

BILLING CODE 4160-01-P