Source: https://www.federalregister.gov/documents/2013/07/15/2013-16258/oral-dosage-form-new-animal-drugs-nicarbazin-oclacitinib-zilpaterol
Timestamp: 2017-08-19 13:43:43
Document Index: 598285333

Matched Legal Cases: ['§\u2009520', '§\u2009520', '§\u2009558', '§\u2009510', '§\u2009510', '§\u2009510', '§\u2009510', '§\u2009558', '§\u2009510', '§\u2009510', '§\u2009510']

Federal Register :: Oral Dosage Form New Animal Drugs; Nicarbazin; Oclacitinib; Zilpaterol
A Rule by the Food and Drug Administration on 07/15/2013
https://www.federalregister.gov/d/2013-16258 https://www.federalregister.gov/d/2013-16258
George K. Haibel, Center for Veterinary Medicine (HFV-6), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-276-9019, ghaibel@fda.hhs.gov.
FDA is amending the animal drug regulations to reflect approval actions for NADAs and ANADAs during May 2013, as listed in table 1. In addition, FDA is informing the public of the availability, where applicable, of documentation of environmental review required under the National Environmental Policy Act (NEPA) and, for actions requiring review of safety or effectiveness data, summaries of the basis of approval (FOI Summaries) under the Freedom of Information Act (FOIA). These public documents 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. Persons with access to the Internet may obtain these documents at the CVM FOIA Electronic Reading Room: http://www.fda.gov/​AboutFDA/​CentersOffices/​OfficeofFoods/​CVM/​CVMFOIAElectronicReadingRoom/​default.htm.
Table 1—Original and Supplemental NADAs and ANADAs Approved During May 2013
141-279 Zoetis Inc., 333 Portage St., Kalamazoo, MI 49007 NICARB 25% (nicarbazin) and BMD (bacitracin methylene disalicylate) Type A medicated articles Supplement revising nicarbazin dosage to a range consistent with dosage approved for use in combination feeds 558.366 No CE 1
141-345 Zoetis Inc., 333 Portage St., Kalamazoo, MI 49007 APOQUEL (oclacitinib tablet) Original approval for control of pruritus associated with allergic dermatitis and control of atopic dermatitis in dogs at least 12 months of age 520.1604 Yes CE 1
200-544 Huvepharma AD, 5th Floor, 3A Nikolay Haytov Str., 1113 Sophia, Bulgaria ZILMAX (zilpaterol hydrochloride) plus RUMENSIN (monensin) plus TYLOVET 100 (tylosin phosphate) plus MGA (melengestrol acetate) Type A medicated articles Original aapproval as a generic copy of NADA 141-280) 528.665 Yes CE 1
2. Add § 520.1604 to read as follows:
§ 520.1604
(a) Specifications. Each tablet contains 3.6, 5.4, or 16 milligrams (mg) of oclacitinib as oclacitinib maleate.
(c) Conditions of use—(1) Amount. Administer orally 0.18 to 0.27 mg/per pound of body weight (0.4 to 0.6 mg/kg body weight) twice daily for up to 14 days; then administered once daily for maintenance therapy.
(2) Indications for use. For control of pruritus associated with allergic dermatitis and control of atopic dermatitis in dogs at least 12 months of age.
4. In § 558.366, in paragraph (d), amend the table by:
a. Revising the entry for “90.8 to 181.6 (0.01 to 0.02 pct)”, and
b. Removing the entry for “Bacitracin methylene disalicylate 4 to 50” under the heading “113.5 (0.0125 pct)”; and
c. Removing the entry for “Bacitracin methylene disalicylate 50” under the heading “113.5 (0.0125 pct)”.
90.8 to 181.6 (0.01 to 0.02 pct) Broiler chickens: As an aid in preventing outbreaks of cecal (Eimeria tenella) and intestinal (E. acervulina, E. maxima, E. necatrix, and E. brunetti) coccidiosis Feed continuously as sole ration from time chicks are placed on litter until past the time when coccidiosis is ordinarily a hazard. Do not use as a treatment for coccidiosis. Do not feed to laying hens. Withdraw 4 days before slaughter for use levels at or below 113.5 g/ton. Withdraw 5 days before slaughter for use levels above 113.5 g/ton 066104
Bacitracin methylene disalicylate 4 to 50 Broiler chickens: As an aid in preventing outbreaks of cecal (Eimeria tenella) and intestinal (E. acervulina, E. maxima, E. necatrix, and E. brunetti) coccidiosis; for increased rate of weight gain and improved feed efficiency Feed continuously as sole ration from time chicks are placed on litter until past the time when coccidiosis is ordinarily a hazard. Do not use as a treatment for coccidiosis. Do not feed to laying hens. Withdraw 4 days before slaughter for use levels at or below 113.5 g/ton. Withdraw 5 days before slaughter for use levels above 113.5 g/ton. Bacitracin methylene disalicylate as provided by No. 054771 in § 510.600(c) of this chapter 054771
Bacitracin methylene disalicylate 4 to 50 and roxarsone 22.7 to 45.4 Broiler chickens: As an aid in preventing outbreaks of cecal (Eimeria tenella) and intestinal (E. acervulina, E. maxima, E. necatrix, and E. brunetti) coccidiosis; for increased rate of weight gain and improved feed efficiency Feed continuously as sole ration from time chicks are placed on litter until past the time when coccidiosis is ordinarily a hazard. Do not use as a treatment for coccidiosis. Discontinue medication 5 days before marketing birds for human consumption. Do not feed to laying hens. Nicarbazin as provided by No. 066104; bacitracin methylene disalicylate and roxarsone as provided by No. 054771 in § 510.600(c) of this chapter 066104
Bacitracin methylene disalicylate 30 Broiler chickens: As an aid in preventing outbreaks of cecal (Eimeria tenella) and intestinal (E. acervulina, E. maxima, E. necatrix, and E. brunetti) coccidiosis; for increased rate of weight gain and improved feed efficiency Feed continuously as sole ration from time chicks are placed on litter until past the time when coccidiosis is ordinarily a hazard. Do not use as a treatment for coccidiosis. Do not feed to laying hens. Withdraw 4 days before slaughter for use levels at or below 113.5 g/ton. Withdraw 5 days before slaughter for use levels above 113.5 g/ton. Bacitracin methylene disalicylate as provided by No. 054771 in § 510.600(c) of this chapter 066104
Bacitracin methylene disalicylate 50 Broiler chickens: As an aid in preventing outbreaks of cecal (Eimeria tenella) and intestinal (E. acervulina, E. maxima, E. necatrix, and E. brunetti) coccidiosis; as an aid in the prevention of necrotic enteritis caused or complicated by Clostridium spp. or other organisms susceptible to bacitracin Feed continuously as sole ration from time chicks are placed on litter until past the time when coccidiosis is ordinarily a hazard. Do not use as a treatment for coccidiosis. Do not feed to laying hens. Withdraw 4 days before slaughter for use levels at or below 113.5 g/ton. Withdraw 5 days before slaughter for use levels above 113.5 g/ton. Bacitracin methylene disalicylate as provided by No. 054771 in § 510.600(c) of this chapter 054771
5. In § 558.665, in the table, in paragraphs (e)(2), (e)(4), and (e)(6), revise the last sentence in the “Limitations” column and revise the “Sponsor” column to read as follows:
(2) * * * Melengestrol acetate as provided by Nos. 000986 or 054771 in § 510.600(c) of this chapter 000061 000986
(4) * * * Monensin as provided by No. 000986; and melengestrol acetate as provided by Nos. 000986 or 054771 in § 510.600(c) of this chapter 000061 000986
(6) * * * Monensin as provided by No. 000986; tylosin as provided by Nos. 000986 or 016592; and melengestrol acetate as provided by Nos. 000986 or 054771 in § 510.600(c) of this chapter 000061 000986 016592
[FR Doc. 2013-16258 Filed 7-12-13; 8:45 am]