E8-29861. New Animal Drugs; Tylosin

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Final rule.

SUMMARY:

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of two supplemental new animal drug applications (NADAs) filed by Elanco Animal Health. The supplemental NADAs provide for use of tylosin tartrate soluble powder in drinking water of swine followed by tylosin phosphate in medicated swine feed for the treatment and control of swine dysentery and the control of porcine proliferative enteropathies.

DATES:

This rule is effective December 18, 2008.

FOR FURTHER INFORMATION CONTACT:

Cindy L. Burnsteel, Center for Veterinary Medicine (HFV-130), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240-276-8341, e-mail: [e-mail].

SUPPLEMENTARY INFORMATION:

Elanco Animal Health, A Division of Eli Lilly & Co., Lilly Corporate Center, Indianapolis, IN 46285, filed a supplement to NADA 12 491 for use of TYLAN (tylosin phosphate) Type A medicated article. The supplement provides for use of tylosin tartrate in medicated drinking water for swine for 3 to 10 days followed by administration of tylosin phosphate in medicated swine feed for 2 to 6 weeks for the control of porcine proliferative enteropathies (PPE, ileitis) associated with Lawsonia intracellularis.

Under section 512(c)(2)(F)(iii) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(iii)), this supplemental approval qualifies for 3 years of marketing exclusivity beginning on the date of approval.

In accordance with the freedom of information provisions of 21 CFR part 20 and 21 CFR 514.11(e)(2)(ii), a summary of safety and effectiveness data and information submitted to support approval of this application may be seen in the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday through Friday.

Elanco Animal Health also filed a supplement to NADA 13 076 for use of TYLAN (tylosin tartrate) Soluble. The supplement provides for use of tylosin tartrate in medicated drinking water for swine for 3 to 10 days followed by administration of tylosin phosphate in medicated swine feed for 2 to 6 weeks for the treatment and control of swine dysentery associated with Brachyspira hyodysenteriae and for the control of porcine proliferative enteropathies (PPE, ileitis) associated with Lawsonia intracellularis.

Under section 512(c)(2)(F)(iii) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(iii)), this supplemental approval qualifies for 3 years of marketing exclusivity beginning on the date of approval. This period of marketing exclusivity applies only to the claim for the control of porcine proliferative enteropathies (PPE, ileitis) associated with Lawsonia intracellularis.

The supplemental NADAs are approved as of November 13, 2008, and the regulations in 21 CFR 520.2640 and 558.625 are amended to reflect the approval.

The agency has determined under 21 CFR 25.33(a)(1) that these actions are of a type that do not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.

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 520

• Animal drugs

21 CFR Part 558

• Animal drugs
• Animal feeds

Therefore, under the Federal Food, Drug, and Cosmetic Act and under the authority delegated to the Commissioner of Food and Drugs and redelegated to the Center for Veterinary Medicine, 21 CFR parts 520 and 558 are amended as follows:

PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS

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

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

2. In § 520.2640, remove paragraph (c); redesignate paragraphs (d) and (e) as paragraphs (c) and (d); and revise paragraphs (a) and newly redesignated paragraphs (d)(1), (d)(2), and (d)(3) to read as follows:

§ 520.2640

Tylosin.

(a) Specifications. Each jar contains tylosin tartrate equivalent to 100 grams tylosin base.

(d) * * *

(1) Chickens—(i) Amount. 2 grams per gallon for 1 to 5 days as the sole source of drinking water. Treated chickens should consume enough medicated drinking water to provide 50 milligrams (mg) tylosin per pound of body weight per day.

(ii) Indications for use. As an aid in the treatment of chronic respiratory disease (CRD) associated with Mycoplasma gallisepticum sensitive to tylosin in broiler and replacement chickens. For the control of chronic respiratory disease (CRD) associated with M. gallisepticum sensitive to tylosin at time of vaccination or other stress in chickens. For the control of chronic respiratory disease (CRD) associated with Mycoplasma synoviae sensitive to tylosin in broiler chickens.

(iii) Limitations. Prepare a fresh solution every 3 days. Do not use in layers producing eggs for human consumption. Do not administer within 24 hours of slaughter.

(2) Turkeys—(i) Amount. 2 grams per gallon for 2 to 5 days as the sole source of drinking water. Treated turkeys should consume enough medicated drinking water to provide 60 mg tylosin per pound of body weight per day.

(ii) Indications for use. For maintaining weight gains and feed efficiency in the presence of infectious sinusitis associated with Mycoplasma gallisepticum sensitive to tylosin.

(iii) Limitations. Prepare a fresh solution every 3 days. Do not use in layers producing eggs for human consumption. Do not administer within 5 days of slaughter.

(3) Swine—(i) Amount. 250 mg per gallon as the only source of drinking water for 3 to 10 days, depending on the severity of the condition being treated.

(ii) Indications for use. For the control and treatment of swine dysentery associated with Brachyspira hyodysenteriae and for the control of porcine proliferative enteropathies (PPE, ileitis) associated with Lawsonia intracellularis.

(iii) Limitations. Prepare a fresh solution daily. Do not administer within 48 hours of slaughter. Follow with tylosin phosphate medicated feed as in § 558.625(f)(1)(vi)(c) of this chapter.

PART 558—NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS

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

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

4. In § 558.625, revise paragraphs (a), (f)(1)(vi)( c)(1), (f)(1)(vi)(c)(2), and (f)(1)(vi)(e)(1) to read as follows:

§ 558.625

Tylosin.

(a) Specifications. Type A medicated articles containing tylosin phosphate.

(f) * * *

(1) * * *

(vi) * * *

(c) * * *

(1) Indications for use. For the treatment and control of swine dysentery associated with Brachyspira hyodysenteriae and for the control of porcine proliferative enteropathies (PPE, ileitis) associated with Lawsonia intracellularis.

(2) Limitations. Administer as tylosin phosphate in feed for 2 to 6 weeks, immediately after treatment with tylosin tartrate in drinking water as in § 520.2640(d)(3) of this chapter.

(e) * * *

(1) Indications for use. For the control of porcine proliferative enteropathies (PPE, ileitis) associated with Lawsonia intracellularis.

Dated: December 10, 2008.

Steven D. Vaughn,

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