New Animal Drugs: Change of Sponsor

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

Rules and Regulations

Federal Register

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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