Document ID: FDA-2010-N-0002-0014
Agency: fda
Document Type: Rule
Title: New Animal Drugs: Change of Sponsor
Posted Date: 2010-03-05T05:00Z

[Federal Register: March 5, 2010 (Volume 75, Number 43)]
[Rules and Regulations]               
[Page 10165-10168]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr05mr10-1]                         

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Rules and Regulations
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains regulatory documents 
having general applicability and legal effect, most of which are keyed 
to and codified in the Code of Federal Regulations, which is published 
under 50 titles pursuant to 44 U.S.C. 1510.

The Code of Federal Regulations is sold by the Superintendent of Documents. 
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[[Page 10165]]

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 520, 522, 524, and 526

[Docket No. FDA-2009-N-0665]

 
New Animal Drugs; Change of Sponsor

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 18 new animal drug 
applications (NADAs) and 1 abbreviated new animal drug application 
(ANADA) from Fort Dodge Animal Health, Division of Wyeth, a wholly 
owned subsidiary of Pfizer, Inc., to Boehringer Ingelheim Vetmedica, 
Inc. (Boehringer). In addition, FDA is amending the animal drug 
regulations to reflect a change of sponsor for 15 NADAs from Fort Dodge 
Animal Health, Division of Wyeth Holdings Corp., a wholly owned 
subsidiary of Pfizer, Inc., to Boehringer.

DATES: This rule is effective March 5, 2010.

FOR FURTHER INFORMATION CONTACT: David R. Newkirk, Center for 
Veterinary Medicine (HFV-100), Food and Drug Administration, 7520 
Standish Pl., Rockville, MD 20855, 240-276-8307, e-mail: 
david.newkirk@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Fort Dodge Animal Health, Division of Wyeth, 
a wholly owned subsidiary of Pfizer, Inc., 235 East 42d St., New York, 
NY 10017 (Pfizer) has informed FDA that it has transferred ownership 
of, and all rights and interest in, the following 18 approved NADAs and 
1 approved ANADA to Boehringer Ingelheim Vetmedica, Inc., 2621 North 
Belt Highway, St. Joseph, MO 64506-2002 (Boehringer): NADA 15-030, 32-
702, 34-879, 45-290, 55-021, 55-022, 55-030, 55-048, 55-054, 55 058, 
97-222, 108-114, 119-688, 140-684, 140-806, 140-854, 141-096, and 141-
274; and ANADA 200-088. In addition, Fort Dodge Animal Health, Division 
of Wyeth Holdings Corp., a wholly owned subsidiary of Pfizer, has 
informed FDA that it has transferred ownership of, and all rights and 
interest in, the following 15 approved NADAs to Boehringer: NADA 6-084, 
8-774, 12-198, 13-624, 33-127, 33-318, 33-319, 33-373, 40-181, 46-146, 
65-269, 99-388, 122-271, 122-272, and 141-108. Accordingly, the agency 
is amending the regulations in 21 CFR parts 520, 522, 524, and 526 to 
reflect the transfer of ownership. In addition, several sections are 
being revised to reflect the current format.
    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 in 21 CFR Parts 520, 522, 524, and 526

    Animal drugs.

0
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 520, 
522, 524, and 526 are amended as follows:

PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS

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

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

0
2. Revise Sec.  520.23 to read as follows:

Sec.  520.23  Acepromazine.

    (a) Specifications. Each tablet contains 5, 10, or 25 milligrams 
(mg) acepromazine maleate.
    (b) Sponsors. See No. 000010 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use--(1) Dogs--(i) Amount. 0.25 to 1.0 mg per 
pound (/lb) body weight orally.
    (ii) Indications for use. As an aid in tranquilization and as a 
preanesthetic agent.
    (iii) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.
    (2) Cats--(i) Amount. 0.5 to 1.0 mg/lb body weight orally.
    (ii) Indications for use. As a tranquilizer.
    (iii) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.

0
3. Revise Sec.  520.314 to read as follows:

Sec.  520.314  Cefadroxil.

    (a) Specifications.--(1) Each tablet contains 50, 100, or 200 
milligrams (mg) or 1 gram of cefadroxil.
    (2) Each milliliter of suspension constituted from powder contains 
50 mg of cefadroxil.
    (b) Sponsor. See No. 000010 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use in dogs and cats--(1) Amount--(i) Dogs. 
Administer 10 mg per pound (/lb) body weight twice daily orally.
    (ii) Cats. Administer 10 mg/lb body weight once daily orally.
    (2) Indications for use--(i) Dogs. For the treatment of skin and 
soft tissue infections including cellulitis, pyoderma, dermatitis, 
wound infections, and abscesses due to susceptible strains of 
Staphylococcus aureus. For the treatment of genitourinary tract 
infections (cystitis) due to susceptible strains of Escherichia coli, 
Proteus mirabilis, and S. aureus.
    (ii) Cats. For the treatment of skin and soft tissue infections 
including abscesses, wound infections, cellulitis, and dermatitis 
caused by susceptible strains of Pasteurella multocida, S. aureus, 
Staphylococcus epidermidis, and Streptococcus spp.
    (3) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.

Sec.  520.315  [Removed]

0
4. Remove Sec.  520.315.

0
5. In Sec.  520.645, in paragraph (b), remove ``000856'' and in its 
place add ``000010''; and revise paragraphs (d)(1)(i)and (d)(1)(iii) to 
read as follows:

Sec.  520.645  Difloxacin.

* * * * *
    (d) * * *
    (1) * * *
    (i) Amount. Administer 5 to 10 mg per kilogram (2.3 to 4.6 mg per 
pound) of body weight orally once a day for 2 to 3 days beyond 
cessation of clinical signs of disease up to a maximum of 30 days.
* * * * *

[[Page 10166]]

    (iii) Limitations. Federal law prohibits the extra-label use of 
this drug in food-producing animals. Federal law restricts this drug to 
use by or on the order of a licensed veterinarian.
* * * * *

0
6. In Sec.  520.870, in paragraph (b), remove ``053501'' and in its 
place add ``No. 000010''; revise paragraphs (d)(1)(i)and (d)(1)(iii to 
read as follows:

Sec.  520.870  Etodolac.

* * * * *
    (d) * * *
    (1) * * *
    (i) Amount. Administer 10 to 15 mg per kilogram (4.5 to 6.8 mg per 
pound) of body weight per day orally.
* * * * *
    (iii) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.
* * * * *

0
7. Revise Sec.  520.1130 to read as follows:

Sec.  520.1130  Hetacillin.

    (a) Specifications.--(1) Each capsule or tablet contains hetacillin 
potassium equivalent to 50, 100, or 200 milligrams (mg) of ampicillin.
    (2) Each milliliter of suspension contains hetacillin potassium 
equivalent to 50 mg of ampicillin.
    (b) Sponsor. See No. 000010 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use in dogs and cats--(1) Amount--(i) Dogs. 
Administer 5 mg per pound (/lb) of body weight orally, twice daily. In 
severe infections, administer 5 mg/lb three times daily, or up to 10 
mg/lb twice daily. For stubborn urinary tract infections, administer up 
to 20 mg/lb twice daily.
    (ii) Cats. Administer 50 mg twice daily.
    (2) Indications for use. For the treatment of respiratory tract 
infections, urinary tract infections, gastrointestinal infections, skin 
infections, soft tissue infections, and postsurgical infections 
associated with strains of organisms susceptible to hetacillin 
potassium.
    (3) Limitations. Federal law restricts this drug to use only by or 
on the order of a licensed veterinarian.

Sec.  520.1130a  [Removed]

0
8. Remove Sec.  520.1130a.

Sec.  520.1130b  [Removed]

0
9. Remove Sec.  520.1130b.

Sec.  520.1130c  [Removed]

0
10. Remove Sec.  520.1130c.

Sec.  520.1630  [Amended]

0
11. In paragraph (b) of Sec.  520.1630, remove ``000856'' and in its 
place add ``No. 000010''.

0
12. Revise Sec.  520.2200 to read as follows:

Sec.  520.2200  Sulfachlorpyridazine.

    (a) Specifications.--(1) Sodium sulfachlorpyridazine powder.
    (2) Each bolus contains 2 grams sulfachlorpyridazine.
    (3) Each tablet contains 250 milligrams (mg) sulfachlorpyridazine.
    (b) Sponsor. See No. 000010 in Sec.  510.600(c) of this chapter.
    (c) Related tolerances. See Sec.  556.630 of this chapter.
    (d) Conditions of use. It is used as follows:
    (1) Calves--(i) Amount. Administer 30 to 45 mg sulfachlorpyridazine 
powder per pound (/lb) of body weight per day in milk or milk replacer, 
or in a bolus, in divided doses twice daily for 1 to 5 days.
    (ii) Indications for use. For the treatment of diarrhea caused or 
complicated by Escherichia coli (colibacillosis).
    (iii) Limitations. Treated ruminating calves must not be 
slaughtered for food during treatment or for 7 days after the last 
treatment. A withdrawal period has not been established for this 
product in preruminating calves. Do not use in calves to be processed 
for veal.
    (2) Swine--(i) Amount. Administer 20 to 35 mg/lb body weight per 
day, in divided doses twice daily for 1 to 5 days:
    (A) In drinking water or
    (B) For individual treatment, in an oral suspension containing 50 
mg per milliliter.
    (ii) Indications for use. For the treatment of diarrhea caused or 
complicated by E. coli (colibacillosis).
    (iii) Limitations. Treated swine must not be slaughtered for food 
during treatment or for 4 days after the last treatment.
    (3) Dogs--(i) Amount. Administer tablets orally at 500 mg per 10 to 
15 lb of body weight daily, in two or three divided doses.
    (ii) Indications for use. As an aid in the treatment of infectious 
tracheobronchitis and infections caused by E. coli, and in the 
treatment of infections caused by other Gram-positive and Gram-negative 
organisms that are susceptible to sulfonamide therapy.
    (iii) Limitations. Federal law restricts this drug to use only by 
or on the order of a licensed veterinarian.

Sec.  520.2200a  [Removed]

0
13. Remove Sec.  520.2200a.

Sec.  520.2200b  [Removed]

0
14. Remove Sec.  520.2200b.

Sec.  520.2200c  [Removed]

0
15. Remove Sec.  520.2200c.

Sec.  520.2260a  [Amended]

0
16. In paragraph (a)(1) of Sec.  520.2260a, remove ``053501'' and in 
its place add ``000010''.

Sec.  520.2261a  [Amended]

0
17. In Sec.  520.2261a, in the first sentence of paragraph (a), remove 
``053501'' and in its place add ``000010''; and remove paragraph (d).

Sec.  520.2261b  [Amended]

0
18. In paragraph (b) of Sec.  520.2261b, remove ``053501'' and in its 
place add ``000010''.

Sec.  520.2345d  [Amended]

0
19. In paragraphs (b)(3), (d)(1)(iii), and (d)(2)(iii) of Sec.  
520.2345d, remove ``053501'' and in its place add ``000010''.

Sec.  520.2481  [Removed]

0
20. Remove Sec.  520.2481.

Sec.  520.2482  [Removed]

0
21. Remove Sec.  520.2482.

0
22. Add Sec.  520.2483 to read as follows:

Sec.  520.2483  Triamcinolone.

    (a) Specifications.--(1) Each tablet contains 0.5 milligram (mg) or 
1.5 mg triamcinolone acetonide.
    (2) Each 15 grams of powder contains 10 mg triamcinolone acetonide.
    (b) Sponsor. See No. 000010 in Sec.  510.600(c) of this chapter.
    (c) Special considerations. See Sec.  510.410 of this chapter.
    (d) Conditions of use--(1) Dogs and cats. Use tablets described in 
paragraph (a)(1) of this section as follows:
    (i) Amount. Administer 0.05 mg per pound (/lb) of body weight daily 
by mouth; up to 0.1 mg per pound (/lb) of body weight daily, if 
response to the smaller dose is inadequate. Therapy may be initiated 
with a single injection of triamcinolone acetonide suspension as in 
Sec.  522.2483 of this chapter, in which case triamcinolone acetonide 
tablets should be administered beginning 5 to 7 days after the 
injection.
    (ii) Indications for use. As an anti-inflammatory agent.
    (iii) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.
    (2) Horses. Use oral powder described in paragraph (a)(2) of this 
section as follows:

[[Page 10167]]

    (i) Amount. Administer 0.005 to 0.01 mg/lb of body weight twice 
daily, sprinkled (top-dressed) on a small portion of feed. Therapy may 
be initiated with a single injection of triamcinolone acetonide 
suspension as in Sec.  522.2483 of this chapter, in which case 
triamcinolone acetonide oral powder should be administered beginning 3 
or 4 days after the injection.
    (ii) Indications for use. As an anti-inflammatory agent.
    (iii) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian. Do not use in horses intended for 
human consumption.

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

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

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

0
24. Revise Sec.  522.23 to read as follows:

Sec.  522.23  Acepromazine.

    (a) Specifications. Each milliliter of solution contains 10 
milligrams (mg) acepromazine maleate.
    (b) Sponsors. See sponsors in Sec.  510.600(c) of this chapter:
    (1) No. 000010 for use as in paragraphs (d) and (e) of this 
section.
    (2) No. 059130 for use as in paragraph (d) of this section.
    (c) Special considerations. Federal law restricts this drug to use 
by or on the order of a licensed veterinarian.
    (d) Conditions of use. It is used in dogs, cats, and horses as 
follows:
    (1) Amount. Dogs: 0.25 to 0.5 mg per pound (/lb) of body weight; 
Cats: 0.5 to 1.0 mg/lb of body weight; Horses: 2.0 to 4.0 mg per 100 
lbs of body weight.
    (2) Indications for use. As a tranquilizer.
    (e) Conditions of use. It is used in dogs as follows:
    (1) Amount. Dogs: 0.25 to 0.5 mg/lb of body weight.
    (2) Indications for use. As an aid in tranquilization and as a 
preanesthetic agent.

Sec.  522.90b  [Amended]

0
25. In Sec.  522.90b, in the section heading, remove ``sterile''; and 
in paragraph (b)(1), remove ``000856'' and in its place add ``No. 
000010''.

Sec.  522.775  [Amended]

0
26. In paragraph (b) of Sec.  522.775, remove ``000856'' and in its 
place add ``000010''.

Sec.  522.870  [Amended]

0
27. In paragraph (b) of Sec.  522.870, remove ``000856'' and in its 
place add ``000010''.

Sec.  522.1145  [Amended]

0
28. In paragraph (c)(2) of Sec.  522.1145, remove ``000856'' and in its 
place add ``No. 000010''.

Sec.  522.1222a  [Amended]

0
29. In paragraph (b) of Sec.  522.1222a, remove ``000856,''.

0
30. Revise Sec.  522.2200 to read as follows:

Sec.  522.2200  Sulfachlorpyridazine.

    (a) Specifications. Each milliliter of solution contains sodium 
sulfachlorpyridazine equivalent to 200 milligrams (mg) 
sulfachlorpyridazine.
    (b) Sponsor. See No. 000010 in Sec.  510.600(c) of this chapter.
    (c) Related tolerances. See Sec.  556.630 of this chapter.
    (d) Conditions of use in calves. It is used as follows:
    (1) Amount. Administer 30 to 45 mg per pound (/lb) of body weight 
in divided doses by twice daily injection for 1 to 5 days.
    (2) Indications for use. For the treatment of diarrhea caused or 
complicated by Escherichia coli (colibacillosis).
    (3) Limitations. Treated calves must not be slaughtered for food 
during treatment or for 5 days after the last treatment. A withdrawal 
period has not been established for this product in preruminating 
calves. Do not use in calves to be processed for veal.

0
31. Amend Sec.  522.2260 as follows:
0
a. Revise the section heading;
0
b. Revise paragraphs (a) and (b);
0
c. Remove paragraph (d);
0
d. Redesignate paragraph (e) as (d); and
0
e. Revise newly redesignated paragraph (d) introductory text and 
paragraph (d)(1).
0
The revisions read as follows:

Sec.  522.2260  Sulfamethazine.

    (a) Specifications. Each milliliter of solution contains 250 
milligrams sulfamethazine sodium.
    (b) Sponsor. See No. 000010 in Sec.  510.600(c) of this chapter.
* * * * *
    (d) Conditions of use in cattle--(1) Amount. 20 milliliters for 
each 50 pounds of body weight (100 milligrams per pound) initially; 20 
milliliters per 100 pounds of body weight (50 milligrams per pound) 
daily, thereafter.
* * * * *

0
32. Revise Sec.  522.2483 to read as follows:

Sec.  522.2483  Triamcinolone.

    (a) Specifications. Each milliliter of suspension contains 2 or 6 
milligrams (mg) triamcinolone acetonide.
    (b) Sponsor. See No. 000010 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use--(1) Dogs and cats--(i) Amount--(A) 
Intramuscular or subcutaneous. For inflammatory, arthritic, or allergic 
disorders, administer 0.05 to 0.1 mg per pound (/lb) of body weight as 
a single injection. For dermatologic disorders, administer 0.1 mg per 
pound (/lb) of body weight as a single injection. If symptoms recur, 
the dose may be repeated, or oral corticosteroid therapy may be 
instituted.
    (B) Intralesional. Administer 1.2 to 1.8 mg, divided in several 
injections around the lesion, spaced 0.5 to 2.5 centimeters apart, 
depending on lesion size. At any one site, the dose injected should not 
exceed 0.6 mg. and should be well into the cutis to prevent rupture of 
the epidermis. When treating animals with multiple lesions, do not 
exceed a total dose of 6 mg.
    (C) Intra-articular and intrasynovial. Administer 1 to 3 mg as a 
single injection, depending on the size of the joint and severity of 
symptoms. After 3 or 4 days, repeat dosage if indicated. If initial 
results are inadequate or too transient, dosage may be increased, not 
to exceed 3 mg.
    (ii) Indications for use. For the treatment of inflammation and 
related disorders, and the management and treatment of acute arthritis 
and allergic and dermatologic disorders.
    (iii) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.
    (2) Horses--(i) Amount--(A) Intramuscular or subcutaneous. 
Administer 0.01 to 0.02 mg/lb of body weight as a single injection. 
Usual dose is 12 to 20 mg.
    (B) Intra-articular and intrasynovial. Administer 6 to 18 mg as a 
single injection, depending on the size of the joint and severity of 
symptoms. After 3 or 4 days, repeat dosage if indicated. If initial 
results are inadequate or too transient, dosage may be increased, not 
to exceed 18 mg.
    (ii) Indications for use. For the treatment of inflammation and 
related disorders.
    (iii) Limitations. Do not use in horses intended for human 
consumption. Federal law restricts this drug to use by or on the order 
of a licensed veterinarian.

Sec.  522.2662  [Amended]

0
33. In paragraph (b)(2) of Sec.  522.2662, remove ``000856'' and in its 
place add ``000010''.

[[Page 10168]]

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

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

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

Sec.  524.2481  [Redesignated as Sec.  524.2483]

0
35. Redesignate Sec.  524.2481 as Sec.  524.2483.

Sec.  524.2483  [Amended]

0
36. In paragraph (b) of newly redesignated Sec.  524.2483, remove 
``015914, 053501, and 054925'' and in its place add ``000010, 015914, 
and 054925''.

PART 526--INTRAMAMMARY DOSAGE FORMS

0
37. The authority citation for 21 CFR part 526 continues to read as 
follows:

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

Sec.  526.363  [Amended]

0
38. In paragraph (b) of Sec.  526.363, remove ``000856'' and in its 
place add ``000010''.

Sec.  526.365  [Amended]

0
39. In paragraph (b) of Sec.  526.365, remove ``000856'' and in its 
place add ``000010''.

0
40. In Sec.  526.464a, revise the section heading and paragraph (c) to 
read as follows:

Sec.  526.464a  Cloxacillin benzathine.

* * * * *
    (c) Sponsor. See No. 000010 in Sec.  510.600(c) of this chapter for 
use in dairy cows.
* * * * *

Sec.  526.1130  [Amended]

0
41. In Sec.  526.1130, in paragraph (b), remove ``000856'' and in its 
place add ``000010''; and in paragraph (c)(3), remove the first 
sentence.

    Dated: February 26, 2010.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 2010-4560 Filed 3-4-10; 8:45 am]
BILLING CODE 4160-01-S