Source: https://www.federalregister.gov/documents/2016/09/30/2016-23230/new-animal-drugs-approval-of-new-animal-drug-applications-change-of-sponsors-address
Timestamp: 2017-08-18 17:44:22
Document Index: 761700003

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67149-67153 (5 pages)
II. Change of Sponsor's Address
https://www.federalregister.gov/d/2016-23230 https://www.federalregister.gov/d/2016-23230
The Food and Drug Administration (FDA, we) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during July and August 2016. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to reflect a change of a sponsor's address.
FDA is amending the animal drug regulations to reflect approval actions for NADAs and ANADAs during July and August 2016, 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. Marketing exclusivity and patent information may be accessed in FDA's publication, Approved Animal Drug Products Online (Green Book) at: http://www.fda.gov/​AnimalVeterinary/​Products/​ApprovedAnimalDrugProducts/​default.htm.
Table 1—Original and Supplemental NADAs and ANADAs Approved During July and August 2016
Effect of the action/indications for use
July 24, 2016 141-458 Merial, Inc., 3239 Satellite Blvd., bldg. 500, Duluth, GA 30096-4640 EQUIOXX (firocoxib) Tablets Horses Original approval for the control of pain and inflammation associated with osteoarthritis in horses FOI Summary.
July 20, 2016 141-459 Intervet, Inc., 2 Giralda Farms, Madison, NJ 07940 BRAVECTO (fluralaner topical solution) for Dogs BRAVECTO (fluralaner topical solution) for Cats Dogs, cats Original approval for killing adult fleas, for the treatment and prevention of flea infestations, and for the treatment and control of tick infestations in dogs and cats FOI Summary.
August 12, 2016 141-461 Aratana Therapeutics, Inc., 11400 Tomahawk Creek Pkwy., Leawood, KS 66211 NOCITA (bupivacaine liposome injectable suspension) Dogs Original approval to provide local postoperative analgesia for cranial cruciate ligament surgery in dogs FOI Summary.
July 1, 2016 200-501 Cross Vetpharm Group Ltd. Broomhill Rd., Tallaght, Dublin 24, Ireland Praziquantel (praziquantel) Injection Dogs Original approval of a generic copy of NADA 111-607 FOI Summary.
August 5, 2016 200-508 Cross Vetpharm Group Ltd. Broomhill Rd., Tallaght, Dublin 24, Ireland BILOVET (tylosin) Injection Cattle, swine Original approval of a generic copy of NADA 012-965 FOI Summary.
Nexcyon Pharmaceuticals, Inc., 644 West Washington Ave., Madison, WI 53719 has informed FDA that it has changed its address to P.O. Box 259158, Madison, WI 53725. Accordingly, the regulations at 21 CFR 510.600(c) will be amended to reflect this sponsor's change of address.
FDA has noticed that drug labeler codes (DLCs) in several sections of part 558 (21 CFR part 558) do not accurately reflect the sponsorship of a new animal drug application. At this time, we are amending part 558 to remove these DLCs. Also, FDA is amending the regulations to revise a human food safety warning for tulathromycin injectable solution in 21 CFR 522.2630 and to correct a cross-reference for combination medicated feeds in § 558.128 (21 CFR 558.128). These actions are being taken to improve the accuracy of the regulations.
The restrictions for veterinary feed directive (VFD) drugs in part 558 are being revised to reflect a uniform text. In addition, we are revising § 558.59 to reflect a current format. These actions are being taken to improve the clarity of the regulations.
End List of Subjects Start Printed Page 67151
2. Revise § 510.600 as follows:
i. In the entries for “Cronus Pharma LLC”, “HQ Specialty Pharma Corp.”, “OXIS International, Inc.”, “Pharmgate LLC “, “Putney, Inc.”, “SmartVet USA, Inc.”, and “Wildlife Laboratories, Inc.”, remove “Suite” and in its place add “suite”;
ii. In the entry for “Merial, Inc.”, remove “Bldg.” and in its place add “bldg.”;
iii. In the entry for “Nexcyon Pharmaceuticals, Inc.”, remove “644 West Washington Ave., Madison, WI 53719” and in its place add “P.O. Box 259158, Madison, WI 53725”;
i. In the entries for “024991”, “026637”, “042791”, “053923”, “069043”, “069254”, and “086001”, remove “Suite” and in its place add “suite”;
ii. In the entry for “050604”, remove “Bldg.” and in its place add “bldg.”; and
iii. In the entry for “050929”, remove “644 West Washington Ave., Madison, WI 53719” and in its place add “P.O. Box 259158, Madison, WI 53725”.
Authority: 21 U.S.C. 360b
4. In § 520.928, revise paragraph (c) to read as follows:
Firocoxib tablets.
(c) Conditions of use—(1) Dogs—(i) Amount. 5 mg/kg (2.27 mg/lb) body weight. Administer once daily for osteoarthritis. Administer approximately 2 hours before soft tissue or orthopedic surgery.
(ii) Indications for use. For the control of pain and inflammation associated with osteoarthritis; and for the control of postoperative pain and inflammation associated with soft-tissue and orthopedic surgery.
(2) Horses—(i) Amount. Administer one 57-mg tablet to horses weighing 800 to 1,300 lb once daily for up to 14 days.
5. In § 520.2345c, remove paragraph (d)(1)(iii).
7. Add § 522.224 to read as follows:
(a) Specifications. Each milliliter (mL) of liposomal suspension contains 13.3 milligrams (mg) bupivacaine.
(c) Conditions of use in dogs—(1) Amount. Administer 5.3 mg/kg (0.4 mL/kg) by infiltration injection into the tissue layers at the time of incisional closure.
(2) Indications for use. For single-dose infiltration into the surgical site to provide local postoperative analgesia for cranial cruciate ligament surgery in dogs.
8. In § 522.1870, revise paragraphs (a), (c)(1)(i) and (iii), and (c)(2)(i) and (iii) to read as follows:
(i) Amount. Administer by subcutaneous or intramuscular injection for dogs and puppies 5 pounds (lb) and under, 0.3 mL; for 6 to 10 lb, 0.5 mL; for 11 to 25 lb, 1.0 mL; if over 25 lb, 0.2 mL/5 lb body weight to a maximum of 3 mL.
(i) Amount. Administer by subcutaneous or intramuscular injection for cats and kittens under 5 lb, 0.2 mL; 5 to 10 lb, 0.4 mL; 11 lb and over, 0.6 mL maximum.
9. In § 522.2630, revise paragraph (d)(1)(iii)(A) to read as follows:
10. Revise § 522.2640 to read as follows:
(2) Nos. 000010 and 061623 for use of a 200-mg/mL solution as in paragraphs (e)(1) and (2) of this section.
(c) Related tolerances. See § 556.740 of this chapter.
(ii) Indications for use. Treatment of bovine respiratory complex (shipping fever, pneumonia) usually associated with Pasteurella multocida and Arcanobacterium pyogenes; foot rot (necrotic pododermatitis) and calf diphtheria caused by Fusobacterium necrophorum and metritis caused by A. pyogenes. Start Printed Page 67152
11. The authority citation for part 524 continues to read as follows:
12. Add § 524.998 to read as follows:
13. The authority citation for part 529 continues to read as follows:
14. In § 529.400, in paragraph (a), remove footnote 1.
16. In § 558.58, in paragraph (e)(6), remove “3.6” and in its place add “36.6”.
17. Revise § 558.59 to read as follows:
(a) Specifications. Each pound of Type A article contains 75 grams apramycin (as apramycin sulfate).
(d) Related tolerances. See § 556.52 of this chapter.
(e) Conditions of use in swine—(1) Amount. Feed at 150 grams apramycin per ton of Type C medicated feed as the sole ration for 14 consecutive days.
(2) Indications for use. For control of porcine colibacillosis (weanling pig scours) caused by susceptible strains of Escherichia coli.
(3) Limitations. Withdraw 28 days before slaughter.
18. In § 558.68, redesignate paragraphs (c) and (d) as paragraphs (d) and (c); and in paragraphs (e)(1)(i) and (e)(2)(i), remove “000986” and in its place add “058198”.
19. In § 558.128, in paragraph (e)(7)(xi), remove “§ 558.600” and in its place add ″§ 558.612″.
20. In § 558.195, in paragraph (e)(1)(vi), remove “000009” and in its place add “054771”; and in paragraphs (e)(2)(iii) and (v), remove “000986” wherever it appears and in its place add “058198”.
21. In § 558.261, redesignate paragraphs (c) and (d) as paragraphs (d) and (c).
22. In § 558.295, remove and reserve paragraph (b).
23. In § 558.325, revise paragraph (d)(3) to read as follows:
(3) Labeling of Type A medicated articles and single-ingredient Type B and Type C medicated feeds containing lincomycin intended for use in swine shall bear the following caution statement: “The effects of lincomycin on swine reproductive performance, pregnancy, and lactation have not been determined. Not for use in swine intended for breeding when lincomycin is fed at 20 grams per ton of complete feed.”
24. In § 558.342, in paragraphs (e)(1)(iv),(ix), (x), and (xi), remove Start Printed Page 67153“000986” wherever it appears and in its place add “058198”.
25. In § 558.366, in paragraph (d), in the entry for “113.5 (0.0125 pct)”, remove “000986” and in its place add “058198”.
26. In § 558.618, redesignate paragraphs (c) and (d) as paragraphs (d) and (c).
27. In § 558.633, revise paragraph (d)(1) to read as follows:
§ 558.633
Tylvalocin.
(1) Federal law restricts medicated feed containing this veterinary feed directive (VFD) drug to use by or on the order of a licensed veterinarian. See § 558.6 for additional requirements.
[FR Doc. 2016-23230 Filed 9-29-16; 8:45 am]