Document ID: FDA-2013-N-0002-0001
Agency: fda
Document Type: Rule
Title: New Animal Drugs: Sponsor Changes
Posted Date: 2013-03-22T04:00Z

[Federal Register Volume 78, Number 56 (Friday, March 22, 2013)]
[Rules and Regulations]
[Pages 17595-17598]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-06126]

[[Page 17595]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510, 520, 522, 524, 529, and 558

[Docket No. FDA-2013-N-0002]

New Animal Drugs; Changes of Sponsor

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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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.

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.

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
------------------------------------------------------------------------
6-391........................  S.Q. (sulfaquinoxaline) 40% Type A
                                Medicated Article.
6-677........................  S.Q. (sulfaquinoxaline) 20% Solution.
7-087........................  Sulfaquinoxaline Solubilized.
33-157.......................  SPECTAM (spectinomycin) Scour Halt.
40-040.......................  SPECTAM (spectinomycin) Injectable
                                Solution.
45-416.......................  TEVCODYNE (phenylbutazone) Injectable
                                Solution.
48-287.......................  Oxytetracycline-50 Injectable Solution.
55-002.......................  TEVCOCIN (chloramphenicol) Injection.
65-110.......................  PEN-G-MAX (penicillin G procaine)
                                Injectable Suspension.
65-498.......................  DUAL-CILLIN (penicillin G benzathine and
                                penicillin G procaine).
91-818.......................  Phenylbutazone Tablets, USP 1 gram.
93-483.......................  SPECTAM (spectinomycin) Injectable
                                Solution.
94-170.......................  Phenylbutazone Tablets, USP 100 or 200
                                mg.
99-169.......................  Oxytocin Injection.
119-142......................  PVL Iron Dextran Injectable (iron
                                hydrogenated dextran injection).
123-815......................  Dexamethasone Sodium Phosphate Injection.
124-241......................  PVL (oxytocin) Injectable.
128-089......................  ZONOMETH (dexamethasone) Solution.
140-270......................  SULFASURE (sulfamethazine) SR Cattle
                                Bolus.
141-070......................  RAPINOVET (propofol) Injectable Emulsion.
141-245......................  TRIBUTAME (embutramide, chloroquine, and
                                lidocaine) Euthanasia Solution.
200-042......................  Ketamine Hydrochloride Injection, USP.
200-068......................  Oxytetracycline Hydrochloride Injection
                                100.
200-069......................  FERTELIN (gonadorelin diacetate
                                tetrahydrate) Injection.
200-108......................  Dexamethasone Solution.
200-118......................  Neomycin Oral Solution.
200-123......................  MAXIM-200 (oxytetracycline hydrochloride)
                                Injection.
200-124......................  Flunixin Meglumine Injection.
200-126......................  Phenylbutazone 20% Injection.
200-137......................  Gentamicin Sulfate Solution (IU).
200-147......................  Gentamicin Sulfate Injection.
200-153......................  NEO 200 (neomycin sulfate) Oral Solution.
200-162......................  Tripelennamine Hydrochloride Injection.
200-174......................  Gentamicin Sulfate Pig Pump Oral
                                Solution.
200-177......................  Sulfadimethoxine Injection 40%.
200-178......................  Amikacin Sulfate Injection.
200-181......................  Amikacin Sulfate Solution.
200-192......................  Sulfadimethoxine 12.5% Oral Solution.
200-193......................  Clindamycin Hydrochloride Oral Liquid.
200-202......................  PHOENECTIN (ivermectin) Oral Solution.
200-219......................  Ivermectin Pour-On for Cattle.
200-228......................  PHOENECTIN (ivermectin) Injectable
                                Solution.
200-230......................  Guaifenesin Injection.
200-246......................  Pyrantel Pamoate Oral Suspension (OTC and
                                Rx).
200-248......................  Pyrantel Pamoate Oral Suspension.
200-253......................  PROSTAMATE (dinoprost tromethamine)
                                Injectable Solution.
200-254......................  Iron Dextran Injection--100.
200-256......................  Iron Dextran Injection--200.
200-265......................  Praziquantel Tablets (OTC and Rx).
200-286......................  PHOENECTIN (ivermectin) Paste 1.87%.
200-287......................  GBC (gentamicin sulfate, betamethasone
                                valerate, and clotrimazole) Ointment.
200-293......................  Furosemide Injection 5%.
200-297......................  Ivermectin Chewable Tablets.
200-298......................  Clindamycin Hydrochloride Capsules.
200-319......................  Acepromazine Maleate Injection.

[[Page 17596]]

 
200-322......................  Butorphanol Tartrate Injection.
200-342......................  Pyrantel Pamoate Paste.
200-351......................  Lincomycin Injectable, USP.
200-360......................  TIAGARD (tiamulin) Liquid Concentrate.
200-365......................  ROBINUL-V (glycopyrrolate) Injectable.
200-382......................  Furosemide Syrup 1%.
200-389......................  Amprolium 9.6% Oral Solution.
200-408......................  Butorphanol Tartrate Injection.
200-463......................  Amprolium-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.

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.

    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:

PART 510--NEW ANIMAL DRUGS

0
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.

Sec.  510.600  [Amended]

0
2. In Sec.  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''.

PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS

0
3. The authority citation for 21 CFR part 520 continues to read as 
follows:

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

Sec.  520.100  [Amended]

0
4. In paragraph (b)(3) of Sec.  520.100, remove ``059130'' and in its 
place add ``000859''.

Sec.  520.446  [Amended]

0
5. In paragraph (b)(1) of Sec.  520.446, remove ``059130'' and in its 
place add ``000859''.

Sec.  520.447  [Amended]

0
6. In paragraph (b) of Sec.  520.447, remove ``000009, 051311, 058829, 
and 059130'' and in its place add ``000009, 000859, 051311, and 
058829''.

Sec.  520.1010  [Amended]

0
7. In paragraph (b)(3) of Sec.  520.1010, remove ``058829 and 059130'' 
and in its place add ``000859 and 058829''.

Sec.  520.1044b  [Amended]

0
8. In paragraph (b) of Sec.  520.1044b, remove ``059130'' and in its 
place add ``000859''.

Sec.  520.1192  [Amended]

0
9. In paragraph (b)(2) of Sec.  520.1192, remove ``051311, 054925, 
059130, and 061623'' and in its place add ``000859, 051311, 054925, and 
061623''.

Sec.  520.1193  [Amended]

0
10. In paragraph (b)(2) of Sec.  520.1193, remove ``051311 and 059130'' 
and in its place add ``000859 and 051311''.

Sec.  520.1195  [Amended]

0
11. In paragraph (b)(1) of Sec.  520.1195, remove ``050604, 054925, and 
059130'' and in its place add ``000859, 050604, and 054925''.

Sec.  520.1484  [Amended]

0
12. In paragraph (b)(3) of Sec.  520.1484, remove ``000009, 054925, 
058005, and 059130'' and in its place add ``000009, 000859, 054925, and 
058005''.

Sec.  520.1720a  [Amended]

0
13. In paragraph (b)(2) of Sec.  520.1720a, remove ``059130'' and in 
its place add ``000859''.

Sec.  520.1870  [Amended]

0
14. In paragraph (b)(2) of Sec.  520.1870, remove ``059130'' and in its 
place add ``000859''.

Sec.  520.2043  [Amended]

0
15. In paragraph (b)(1) of Sec.  520.2043, remove ``000069, 058829, and 
059130'' and in its place add '' 000069, 000859, and 058829''.

Sec.  520.2044  [Amended]

0
16. In paragraph (b)(2) of Sec.  520.2044, remove ``059130'' and in its 
place add ``000859''.

Sec.  520.2123c  [Amended]

0
17. In paragraph (b) of Sec.  520.2123c, remove ``059130'' and in its 
place add ``000859''.

Sec.  520.2220a  [Amended]

0
18. In paragraph (a)(1) of Sec.  520.2220a, remove ``000010, 000069, 
054925, 057561, and 059130'' and in its place add ``000010, 000069, 
000859, 054925, and 057561''.

Sec.  520.2260b  [Amended]

0
19. In paragraph (f)(1) of Sec.  520.2260b, remove ``059130'' and in 
its place add ``000859''.

Sec.  520.2325a  [Amended]

0
20. In paragraph (a)(1) of Sec.  520.2325a, remove ``059130'' and in 
its place add ``000859''.

0
21. In Sec.  520.2455, revise paragraph (b)(2) and add paragraph (b)(3) 
to read as follows:

Sec.  520.2455  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.
* * * * *

[[Page 17597]]

PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

0
22. The authority citation for 21 CFR part 522 continues to read as 
follows:

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

Sec.  522.23  [Amended]

0
23. In paragraph (b)(2) of Sec.  522.23, remove ``059130'' and in its 
place add ``000859''.

Sec.  522.56  [Amended]

0
24. In paragraph (b) of Sec.  522.56, remove ``059130'' and in its 
place add ``000859''.

Sec.  522.246  [Amended]

0
25. In Sec.  522.246, in paragraphs (b)(2) and (b)(3), remove 
``059130'' and in its place add ``000859''.

Sec.  522.390  [Amended]

0
26. In paragraph (b) of Sec.  522.390, remove ``059130'' and in its 
place add ``000859''.

Sec.  522.540  [Amended]

0
27. In Sec.  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.

Sec.  522.810  [Amended]

0
28. In paragraph (b) of Sec.  522.810, remove ``059130'' and in its 
place add ``000859''.

Sec.  522.1010  [Amended]

0
29. In paragraph (b)(3) of Sec.  522.1010, remove ``059130'' and in its 
place add ``000859''.

Sec.  522.1044  [Amended]

0
30. In paragraph (b)(4) of Sec.  522.1044, remove ``059130'' and in its 
place add ``000859''.

Sec.  522.1066  [Amended]

0
31. In paragraph (b) of Sec.  522.1066, remove ``059130'' and in its 
place add ``000859''.

Sec.  522.1086  [Amended]

0
32. In paragraph (b) of Sec.  522.1086, remove ``037990 and 059130'' 
and in its place add ``000859 and 037990''.

Sec.  522.1182  [Amended]

0
33. In Sec.  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''.

Sec.  522.1192  [Amended]

0
34. In paragraph (b)(2) of Sec.  522.1192, remove ``055529, 058005, 
059130, and 061623'' and in its place add ``000859 055529, 058005, and 
061623''.

Sec.  522.1222a  [Amended]

0
35. In paragraph (b) of Sec.  522.1222a, remove ``059130'' and in its 
place add ``000859''.

Sec.  522.1260  [Amended]

0
36. In paragraph (b)(2) of Sec.  522.1260, remove ``058005 and 059130'' 
and in its place add ``000859 and 058005''.

Sec.  522.1660a  [Amended]

0
37. In paragraph (b) of Sec.  522.1660a, remove ``000010, 000069, 
048164, 055529, 057561, 059130, and 061623'' and in its place add 
``000010, 000069, 000859, 048164, 055529, 057561, and 061623''.

Sec.  522.1662a  [Amended]

0
38. In paragraph (i)(2) of Sec.  522.1662a, remove ``059130'' and in 
its place add ``000859''.

Sec.  522.1680  [Amended]

0
39. In paragraph (b) of Sec.  522.1680, remove ``000010, 000856, 
059130, 059130, and 061623'' and in its place add ``000010, 000856, 
000859, and 061623''.

Sec.  522.1696a  [Amended]

0
40. In paragraph (b)(2) of Sec.  522.1696a, remove ``055529, 059130, 
and 061623'' and in its place add ``000859, 055529, and 061623''.

Sec.  522.1696b  [Amended]

0
41. In Sec.  520.1696b:
0
a. In paragraph (b)(1), remove ``053501, 055529, and 059130'' and in 
its place add ``000859, 053501, and 055529''.
0
b. In paragraph (d)(2)(i)(A), remove ``053501, 055529, 059130, and 
061623'' and in its place add ``000859, 053501, 055529, and 061623''.
0
c. In paragraph (d)(2)(iii)(B), remove ``055529 and 059130'' and in its 
place add ``000859 and 055529''.

Sec.  522.1720  [Amended]

0
42. In paragraph (b)(1) of Sec.  522.1720, remove ``059130'' and in its 
place add ``000859''.

Sec.  522.2005  [Amended]

0
43. In paragraph (b)(1) of Sec.  522.2005, remove ``059130'' and in its 
place add ``000859''.

Sec.  522.2120  [Amended]

0
44. In paragraph (b) of Sec.  522.2120, remove ``059130'' and in its 
place add ``000859''.

Sec.  522.  2220 [Amended]

0
45. In paragraph (a)(2)(iii) of Sec.  522.2220, remove ``059130'' and 
in its place add ``000859''.

Sec.  522.2615  [Amended]

0
46. In paragraph (b) of Sec.  522.2615, remove ``053501 and 059130'' 
and in its place add ``000859 and 053501''.

PART 524--OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS

0
47. The authority citation for 21 CFR part 524 continues to read as 
follows:

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

Sec.  524.1044g  [Amended]

0
48. In paragraph (b)(3) of Sec.  524.1044g, remove ``059130'' and in 
its place add ``000859''.

Sec.  524.1193  [Amended]

0
49. In paragraph (b)(2) of Sec.  524.1193, remove ``054925, 059130, and 
066916'' and in its place add ``000859, 054925, and 066916''.

PART 529--CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS

0
50. The authority citation for 21 CFR part 529 continues to read as 
follows:

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

Sec.  529.56  [Amended]

0
51. In paragraph (b) of Sec.  529.56, remove ``059130'' and in its 
place add ``000859''.

Sec.  529.1044a  [Amended]

0
52. In paragraph (b) of Sec.  529.1044a, remove ``000010, 000061, 
000856, 057561, 058005, 059130, and 061623'' and in its place add 
``000010, 000061, 000856, 000859, 057561, 058005, and 061623''.

PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS

0
53. The authority citation for 21 CFR part 558 continues to read as 
follows:

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

Sec.  558.586  [Amended]

0
54. In paragraph (b) of Sec.  558.586, remove ``059130'' and in its 
place add ``000859''.

[[Page 17598]]

    Dated: March 12, 2013.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 2013-06126 Filed 3-21-13; 8:45 am]
BILLING CODE 4160-01-P