Source: https://www.federalregister.gov/documents/2013/10/25/2013-25172/new-animal-drugs-change-of-sponsor-gonadorelin-ivermectin-ractopamine-trimethoprim-and-sulfadiazine
Timestamp: 2018-04-25 06:00:57
Document Index: 540877788

Matched Legal Cases: ['arts 520', '§\u2009510', '§\u2009520', '§\u2009520', '§\u2009522', '§\u2009510', '§\u2009522', '§\u2009510', '§\u2009524', '§\u2009558']

Federal Register :: New Animal Drugs; Change of Sponsor; Gonadorelin; Ivermectin; Ractopamine; Trimethoprim and Sulfadiazine Suspension; Tulathromycin
New Animal Drugs; Change of Sponsor; Gonadorelin; Ivermectin; Ractopamine; Trimethoprim and Sulfadiazine Suspension; Tulathromycin
78 FR 63870
63870-63872 (3 pages)
21 CFR Parts 520, 522 and 524
https://www.federalregister.gov/d/2013-25172 https://www.federalregister.gov/d/2013-25172
George K. Haibel, Center for Veterinary Medicine (HFV-6), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855; 240-276-9019; george.haibel@fda.hhs.gov.
FDA is amending the animal drug regulations to reflect approval actions for NADAs and ANADAs during July 2013, as listed in table 1. In addition, FDA is informing the public of the availability, where Start Printed Page 63871applicable, 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.
In addition, ECO LLC, 344 Nassau St., Princeton, NJ 08540 has informed FDA that it has transferred ownership of, and all rights and interest in, ANADA 200-348 for ECOMECTIN (ivermectin) Topical Solution to SmartVet USA, Inc., 22201 West Innovation Dr., Suite 170A, Olathe, KS 66061-1304. Accordingly, the Agency is amending the regulations to reflect this change of sponsorship.
Table 1—Original and Supplemental NADAs and ANADAs Approved During July 2013
139-237 Zoetis Inc., 333 Portage St., Kalamazoo, MI 49007 FACTREL (gonadorelin injection) Injection Supplemental approval for use with LUTALYSE (dinoprost tromethamine) Sterile Solution to synchronize estrous cycles to allow fixed-time artificial insemination (FTAI) in lactating dairy cows 522.1077 Yes CE 1
141-349 Zoetis Inc., 333 Portage St., Kalamazoo, MI 49007 DRAXXIN 25 (tulathromycin) Injectable Solution Original approval for the treatment and control of swine respiratory disease (SRD) 522.2630 Yes CE 1
141-360 Aurora Pharmaceutical, LLC, 1196 Highway 3 South, Northfield, MN 55057-3009 EQUISUL-SDT (sulfadiazine/trimethoprim) Oral Suspension Original approval for the treatment of lower respiratory tract infections in horses caused by susceptible strains of Streptococcus equi subsp. zooepidemicus 520.2612 Yes CE 1
200-542 Zoetis Inc., 333 Portage St., Kalamazoo, MI 49007 ENGAIN 9 and ENGAIN 45 (ractopamine hydrochloride) Type A medicated articles Original approval as a generic copy of NADA 140-863 558.500 Yes CE 1
200-548 Zoetis Inc., 333 Portage St., Kalamazoo, MI 49007 ACTOGAIN 45 (ractopamine hydrochloride) Type A medicated articles Original approval as a generic copy of NADA 141-221 558.500 Yes CE 1
, 522 and 524
2. In § 510.600, in the table in paragraph (c)(1), alphabetically add entries for “Aurora Pharmaceutical, LLC” and “SmartVet USA, Inc.”; and in the table in paragraph (c)(2), numerically add entries for “051072” and “086001” to read as follows:
Aurora Pharmaceutical, LLC, 1196 Highway 3 South, Northfield, MN 55057-3009 051072
SmartVet USA, Inc., 22201 West Innovation Dr., Suite 170A, Olathe, KS 66061-1304 086001
Start Printed Page 63872
051072 Aurora Pharmaceutical, LLC, 1196 Highway 3 South, Northfield, MN 55057-3009
086001 SmartVet USA, Inc., 22201 West Innovation Dr., Suite 170A, Olathe, KS 66061-1304
4. Revise § 520.2612 to read as follows:
§ 520.2612
Trimethoprim and sulfadiazine suspension.
(a) Specifications. Each milliliter (mL) of suspension contains:
(1) 10 milligrams (mg) trimethoprim and 50 mg sulfadiazine; or
(2) 400 mg combined active ingredients (67 mg trimethoprim and 333 mg sulfadiazine).
(1) No. 000061 for use of product described in paragraph (a)(1) for use as in paragraph (c)(1) of this section.
(2) No. 051072 for use of product described in paragraph (a)(2) for use as in paragraph (c)(2) of this section.
(c) Conditions of use—(1) Dogs—(i) Amount. Administer 1 mL (10 mg trimethoprim and 50 mg sulfadiazine) per 5 pounds (lb) of body weight once daily, or one-half the recommended daily dose every 12 hours, for up to 14 consecutive days.
(ii) Indications for use. The drug is used in dogs where systemic antibacterial action against sensitive organisms is required, either alone or as an adjunct to surgery or debridement with associated infection. The drug is indicated where control of bacterial infection is required during the treatment of acute urinary tract infections, acute bacterial complications of distemper, acute respiratory tract infections, acute alimentary tract infections, wound infections, and abscesses.
(2) Horses—(i) Amount. Administer 24 mg combined active ingredients per kilogram of body weight (2.7 mL/100 lb) twice daily for 10 days.
(ii) Indications for use. For the treatment of lower respiratory tract infections in horses caused by susceptible strains of Streptococcus equi subsp. zooepidemicus.
6. Revise § 522.1077 to read as follows:
Gonadorelin hydrochloride.
(a) Specifications. Each milliliter of solution contains 50 micrograms (mcg) of gonadorelin (as hydrochloride).
(c) Conditions of use in cattle—(1) Indications for use and amounts—(i) For the treatment of ovarian follicular cysts in cattle, administer 100 mcg gonadorelin by intramuscular injection.
(ii) For use with dinoprost tromethamine to synchronize estrous cycles to allow fixed-time artificial insemination (FTAI) in lactating dairy cows, administer to each cow 100 to 200 mcg gonadorelin by intramuscular injection, followed 6 to 8 days later by 25 mg dinoprost tromethamine by intramuscular injection, followed 30 to 72 hours later by 100 to 200 mcg gonadorelin by intramuscular injection.
(2) Limitations. Dinoprost tromethamine as provided by sponsor No. 054771 in § 510.600(c) of this chapter. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
7. In § 522.2630, revise paragraphs (a) and (b) to read as follows:
(b) Sponsor. See No. 054771 in § 510.600(c) of this chapter for use as in paragraph (d) of this section:
(1) Product described as in paragraph (a)(1) for use as in paragraph (d).
(2) Product described as in paragraph (a)(2) for use as in paragraph (d)(2).
9. In paragraph (b)(2) of § 524.1193, remove “066916” and in its place add “086001”.
11. In § 558.500, in paragraph (a), remove “45” and in its place add “45.4”; in paragraph (b), remove “No. 000986” and in its place add “Nos. 000986 and 054771”; in the table in paragraph (e)(1), in the “Ractopamine in grams/ton” column, remove “4.5 to 9” wherever it occurs and in its place add “4.5 to 9.0”; and in the table in paragraphs (e)(1)(i), (e)(2)(i), (e)(2)(vi), and (e)(2)(xi), in the “Sponsor” column, add “054771”.
[FR Doc. 2013-25172 Filed 10-24-13; 8:45 am]