Source: https://www.federalregister.gov/documents/2018/03/30/2018-06358/new-animal-drugs-approval-of-new-animal-drug-applications-withdrawal-of-approval-of-new-animal-drug
Timestamp: 2019-09-19 23:07:40
Document Index: 47106609

Matched Legal Cases: ['§\u2009510', '§\u2009510', '§\u2009510', '§\u2009510', '§\u2009510', '§\u2009520', '§\u2009520', '§\u2009520', '§\u2009520', '§\u2009522', '§\u2009522', '§\u2009510', '§\u2009522', '§\u2009522', '§\u2009522', '§\u2009524', '§\u2009524', '§\u2009556', '§\u2009524', '§\u2009524', 'art 556', '§\u2009556', '§\u2009522', '§\u2009522', 'art 558', '§\u2009558', '§\u2009558', '§\u2009510', '§\u2009558', '§\u2009510', '§\u2009558', '§\u2009510', '§\u2009558', '§\u2009558']

Federal Register :: New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Changes of Sponsorship; Change of a Sponsor's Name and Address
https://www.federalregister.gov/d/2018-06358 https://www.federalregister.gov/d/2018-06358
FDA is amending the animal drug regulations to reflect approval actions for NADAs and ANADAs during July, August, and September 2017, 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 Dockets Management Staff (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: https://www.fda.gov/​AboutFDA/​CentersOffices/​OfficeofFoods/​CVM/​CVMFOIAElectronicReadingRoom/​default.htm. Marketing exclusivity and patent information may be accessed in FDA's publication, Approved Animal Drug Products Online (Green Book) at: https://www.fda.gov/​AnimalVeterinary/​Products/​ApprovedAnimalDrugProducts/​default.htm.
Table 1—Original and Supplemental NADAs and ANADAs Approved During July, August, and September 2017
July 21, 2017 141-450 Intervet, Inc., 2 Giralda Farms, Madison, NJ 07940 BANAMINE Transdermal (flunixin transdermal solution) Solution Cattle Original approval for the control of pyrexia associated with bovine respiratory disease and the control of pain associated with foot rot in steers, beef heifers, beef cows, beef bulls intended for slaughter, and replacement dairy heifers under 20 months of age FOI Summary; EA/FONSI.1
July 19, 2017 141-336 ECO LLC, 344 Nassau St., Princeton, NJ 08540 AIVLOSIN (tylvalosin tartrate) Water Soluble Granules Swine Supplemental approval for control of swine respiratory disease (SRD) associated with Bordetella bronchiseptica, Haemophilus parasuis, Pasteurella multocida, and Streptococcus suis in groups of swine in buildings experiencing an outbreak of SRD FOI Summary.
July 14, 2017 200-620 Aurora Pharmaceutical, LLC, 1196 Highway 3 South, Northfield, MN 55057-3009 ALTREN (altrenogest) Solution Horses Original approval as a generic copy of NADA 131-310 FOI Summary.
July 14, 2017 200-621 Aurora Pharmaceutical, LLC, 1196 Highway 3 South, Northfield, MN 55057-3009 SWINEMATE (altrenogest) Solution Swine Original approval as a generic copy of NADA 141-222 FOI Summary.
September 15, 2017 141-250 Zoetis Inc., 333 Portage St., Kalamazoo, MI 49007 Chlortetracycline and lasalocid Type B and Type C medicated feeds Cattle Supplemental approval of revised representative labeling making technical amendments
September 28, 2017 141-333 Virbac AH, Inc., 3200 Meacham Blvd., Ft. Worth, TX 76137 SENTINEL SPECTRUM (milbemycin oxime/lufenuron/praziquantel) Dogs Supplemental approval for the treatment and control of the adult tapeworm Dipylidium caninum FOI Summary.
SmartVet USA, Inc., 22201 West Innovation Dr., suite 170A, Olathe, KS 66061-1304 has informed FDA that it has transferred ownership of, and all rights and interest in, the following application to Sparhawk Laboratories, Inc., 12340 Santa Fe Trail Dr., Lenexa, KS 66215:
200-348 ECOMECTIN (ivermectin) Topical Solution 524.1193
Following this withdrawal of approval, SmartVet USA, Inc. is no longer the sponsor of an approved application. Accordingly, it will be removed from the list of sponsors of approved applications in § 510.600(c) (21 CFR 510.600(c)).
Strategic Veterinary Pharmaceuticals, Inc., 100 NW. Airport Rd., St. Joseph, MO 64503 has informed FDA that it has transferred ownership of, and all rights and interest in, the following application to Cross Vetpharm Group Ltd., Broomhill Rd., Tallaght, Dublin 24, Ireland:
109-305 Oxytocin Injection 522.1680
The following sponsors requested that FDA withdraw approval of the NADAs listed in the following table because the products are no longer manufactured or marketed:
Following this withdrawal of approval, Watson Laboratories, Inc. is no longer the sponsor of an approved application. Accordingly, it will be removed from the list of sponsors of approved applications in § 510.600(c).
Elsewhere in this issue of the Federal Register, FDA gave notice that approval of NADAs 047-055, 104-606, and 139-633, and all supplements and amendments thereto, is withdrawn, effective April 9, 2018. As provided in the regulatory text of this document, the animal drug regulations are amended to reflect these actions.
Western Chemical, Inc., 1269 Lattimore Rd., Ferndale, WA 98248 has informed FDA that it has changed its name and address to Syndel USA, 1441 W. Smith Rd., Ferndale, WA 98248. ADM Alliance Nutrition, Inc., 1000 North 30th St., Quincy, IL 62305-3115 has informed FDA that it has changed its name to ADM Animal Nutrition, Inc. Accordingly, we are amending § 510.600(c) to reflect these changes.
We are also making technical amendments to update the scientific name of a pathogenic bacterium, to accurately list the concentrations of ingredients in a combination new animal drug, and to correctly list the assay limits and maximum drug concentration in Type B medicated feeds for a combination new animal drug used in feed. These actions are being taken to improve the accuracy of the regulations.
2. In § 510.600, in the table in paragraph (c)(1), remove the entries for “ADM Alliance Nutrition, Inc.”, “SmartVet USA, Inc.” and “Western Chemical, Inc.”, and add entries for “ADM Animal Nutrition, Inc.” and “Syndel USA” in alphabetical order; and in the table in paragraph (c)(2), remove the entry for “086001” and revise the entries for “012286” and “050378” to read as follows:
3. Effective April 9, 2018,” in § 510.600, in the table in paragraph (c)(1), remove the entry for “Watson Laboratories, Inc.”; and in the table in paragraph (c)(2), remove the entry for “000402”.
5. In § 520.48, in paragraph (b), remove “000061 and 061623” and in its place add “000061, 051072, and 061623”.
6. In § 520.1447, in paragraph (d)(1)(ii), remove “( Taenia pisiformis, Echinococcus multilocularis, and E. granulosus)” and in its place add “(Dipylidium caninum, Taenia pisiformis, Echinococcus multilocularis, and E. granulosus)”.
7. In § 520.2645, revise paragraphs (d)(1) and (2) to read as follows:
§ 520.2645
(1) Amount. Administer 50 parts per million (ppm) tylvalosin continuously in drinking water for 5 consecutive days.
(2) Indications for use. For control of porcine proliferative enteropathy (PPE) associated with Lawsonia intracellularis infection in groups of swine in buildings experiencing an outbreak of PPE; and for control of swine respiratory disease (SRD) associated with Bordetella bronchiseptica, Haemophilus parasuis, Pasteurella multocida, and Streptococcus suis in groups of swine in buildings experiencing an outbreak of SRD.
9. Effective April 9, 2018, remove § 522.300.
10. Effective April 9, 2018, in § 522.540, revise paragraphs (b)(2) and (c)(2) to read as follows:
(2) Sponsor. See No. 061623 in § 510.600(c) of this chapter.
11. Effective April 9, 2018, in § 522.1081, in paragraph (b)(1), remove “Nos. 000402 and 054771” and in its place add “No. 054771”.
12. In § 522.1662a, in paragraph (h)(3)(ii), remove “ Spherophorus necrophorus” and in its place add “Fusobacterium necrophorum”.
13. In § 522.1680, in paragraph (b), remove “054628,”.
15. Add § 524.970 to read as follows:
§ 524.970
(c) Related tolerances. See § 556.286 of this chapter.
16. In § 524.1132, revise paragraph (a) to read as follows:
17. In § 524.1193, in paragraph (b)(2), remove “086001” and in its place add “058005”.
18. The authority citation for part 556 continues to read as follows:
19. In § 556.286, in paragraph (c), remove “§§ 522.956 and 522.970” and in its place add “§§ 522.956, 522.970, and 524.970”.
20. The authority citation for part 558 continues to read as follows:
21. In § 558.4, in paragraph (d), in the “Category II” table, revise the row entries for “Neomycin” through “Pyrantel tartrate” to read as follows:
Assay limits percent 1 Type A 1
Neomycin sulfate 80-120 100 g/lb (22.0%) 70-125
Nicarbazin (granular) 90-110 5.675 g/lb (1.25%) 85-115/75-125
Narasin 90-110 5.675 g/lb (1.25%) 85-115/75-125
Nicarbazin (powder) 98-106 5.675 g/lb (1.25%) 85-115/80-120
Novobiocin 85-115 17.5 g/lb (3.85%) 80-120
Pyrantel tartrate 90-110 36 g/lb (7.9%) 75-125
22. In § 558.128, revise paragraphs (e)(3)(vi), (e)(4)(ix), and (e)(4)(xxvi) to read as follows:
(vi) 10 mg/lb of body weight Tiamulin hydrogen fumarate, 35 For control of swine dysentery associated with Brachyspira (formerly Serpulina or Treponema) hyodysenteriae susceptible to tiamulin and for treatment of swine bacterial enteritis caused by E. coli and Salmonella choleraesuis sensitive to chlortetracycline and treatment of bacterial pneumonia caused by P. multocida sensitive to chlortetracycline Feed chlortetracycline at approximately 400 g/ton of feed, varying with body weight and food consumption, to provide 10 mg/lb of body weight. Feed continuously as the sole ration for 14 days. Withdraw medicated feed 2 days before slaughter. Tiamulin as provided by Nos. 058198 or 069254 in § 510.600(c) of this chapter 058198 069254
(ix) 500 to 4,000 to provide 10 mg/lb of body weight daily Lasalocid, 30 to 600 Pasture cattle (slaughter, stocker, feeder cattle, dairy and beef replacement heifers): For treatment of bacterial enteritis caused by E. coli and bacterial pneumonia caused by P. multocida organisms susceptible to chlortetracycline; and for increased rate of weight gain Feed continuously on a hand-fed basis for not more than 5 days to provide 10 mg chlortetracycline per lb. body weight per day and not less than 60 mg or more than 300 mg lasalocid per head per day in at least 1 pound of feed. Daily lasalocid intakes in excess of 200 mg/head/day in pasture cattle have not been shown to be more effective than 200 mg lasalocid/head/day. Do not allow horses or other equines access to feeds containing lasalocid. No withdrawal period is required. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. See § 558.311(d) of this chapter. Lasalocid as provided by No. 054771 in § 510.600(c) of this chapter 054771
(xxvi) 500 to 4,000 to provide 10 mg/head/day Lasalocid, 30 to 181.8 Cattle weighing up to 800 pounds: For the treatment of bacterial enteritis caused by E. coli and bacterial pneumonia caused by P. multocida susceptible to chlortetracycline; and for the control of coccidiosis caused by Eimeria bovis and E. zuernii Hand feed continuously for not more than 5 days at a rate of 10 mg chlortetracycline and 1 mg lasalocid per 2.2 lb. body weight daily to cattle with a maximum of 360 mg of lasalocid per head per day. Do not allow horses or other equines access to feeds containing lasalocid. No withdrawal period is required. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. See § 558.311(d) of this chapter. Lasalocid as provided by No. 054771 in § 510.600(c) of this chapter 054771
23. In § 558.325, revise paragraph (d)(2) to read as follows:
24. In § 558.575, in paragraph (e)(2)(ii) remove “and bacterial infections due to H. galmaxima,”.
[FR Doc. 2018-06358 Filed 3-29-18; 8:45 am]