Document ID: FDA-2016-N-0002-0030
Agency: fda
Document Type: Rule
Title: New Animal Drugs: Approval of New Animal Drug Applications; Change of Sponsor's Address
Posted Date: 2016-09-30T04:00Z

[Federal Register Volume 81, Number 190 (Friday, September 30, 2016)]
[Rules and Regulations]
[Pages 67149-67153]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-23230]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510, 520, 522, 524, 529, and 558

[Docket No. FDA-2016-N-0002]

New Animal Drugs; Approval of New Animal Drug Applications; 
Change of Sponsor's Address

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; technical amendment.

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SUMMARY: 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.

[[Page 67150]]

DATES: This rule is effective September 30, 2016.

FOR FURTHER INFORMATION CONTACT: George K. Haibel, Center for 
Veterinary Medicine (HFV-6), Food and Drug Administration, 7519 
Standish Pl., Rockville, MD 20855, 240-402-5689, 
george.haibel@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: 

I. Approval Actions

    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
         Approval date            File No.        Sponsor          Product name             Species          action/indications      Public documents
                                                                                                                   for use
--------------------------------------------------------------------------------------------------------------------------------------------------------
July 24, 2016..................    141-458  Merial, Inc., 3239  EQUIOXX             Horses.................  Original approval   FOI Summary.
                                             Satellite Blvd.,    (firocoxib)                                  for the control
                                             bldg. 500,          Tablets.                                     of pain and
                                             Duluth, GA 30096-                                                inflammation
                                             4640.                                                            associated with
                                                                                                              osteoarthritis in
                                                                                                              horses.
July 20, 2016..................    141-459  Intervet, Inc., 2   BRAVECTO            Dogs, cats.............  Original approval   FOI Summary.
                                             Giralda Farms,      (fluralaner                                  for killing adult
                                             Madison, NJ 07940.  topical solution)                            fleas, for the
                                                                 for Dogs.                                    treatment and
                                                                BRAVECTO                                      prevention of
                                                                 (fluralaner                                  flea
                                                                 topical solution)                            infestations, and
                                                                 for Cats.                                    for the treatment
                                                                                                              and control of
                                                                                                              tick infestations
                                                                                                              in dogs and cats.
August 12, 2016................    141-461  Aratana             NOCITA              Dogs...................  Original approval   FOI Summary.
                                             Therapeutics,       (bupivacaine                                 to provide local
                                             Inc., 11400         liposome                                     postoperative
                                             Tomahawk Creek      injectable                                   analgesia for
                                             Pkwy., Leawood,     suspension).                                 cranial cruciate
                                             KS 66211.                                                        ligament surgery
                                                                                                              in dogs.
July 1, 2016...................    200-501  Cross Vetpharm      Praziquantel        Dogs...................  Original approval   FOI Summary.
                                             Group Ltd.          (praziquantel)                               of a generic copy
                                             Broomhill Rd.,      Injection.                                   of NADA 111-607.
                                             Tallaght, Dublin
                                             24, Ireland.
August 5, 2016.................    200-508  Cross Vetpharm      BILOVET (tylosin)   Cattle, swine..........  Original approval   FOI Summary.
                                             Group Ltd.          Injection.                                   of a generic copy
                                             Broomhill Rd.,                                                   of NADA 012-965.
                                             Tallaght, Dublin
                                             24, Ireland.
--------------------------------------------------------------------------------------------------------------------------------------------------------

II. Change of Sponsor's Address

    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.

III. Technical Amendments

    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 Sec.  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 Sec.  558.59 to reflect a current format. These actions are 
being taken to improve the clarity of the regulations.
    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 510

    Administrative practice and procedure, Animal drugs, Labeling, 
Reporting and recordkeeping requirements.

21 CFR Parts 520, 522, 524, and 529

    Animal drugs.

21 CFR Part 558

    Animal drugs, Animal feeds.

[[Page 67151]]

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs and 
redelegated to the Center for Veterinary Medicine, 21 CFR parts 510, 
520, 522, 524, 529, and 558 are amended as follows:

PART 510--NEW ANIMAL DRUGS

0
1. The authority citation for part 510 continues to read as follows:

    Authority:  21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e.

Sec.  510.600  [Amended]

0
2. Revise Sec.  510.600 as follows:
0
a. In the table in paragraph (c)(1):
0
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'';
0
ii. In the entry for ``Merial, Inc.'', remove ``Bldg.'' and in its 
place add ``bldg.'';
0
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'';
0
b. In the table in paragraph (c)(2):
0
i. In the entries for ``024991'', ``026637'', ``042791'', ``053923'', 
``069043'', ``069254'', and ``086001'', remove ``Suite'' and in its 
place add ``suite'';
0
ii. In the entry for ``050604'', remove ``Bldg.'' and in its place add 
``bldg.''; and
0
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''.

PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS

0
3. The authority citation for part 520 continues to read as follows:

    Authority:  21 U.S.C. 360b

0
4. In Sec.  520.928, revise paragraph (c) to read as follows:

Sec.  520.928  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.
    (iii) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.
    (2) Horses--(i) Amount. Administer one 57-mg tablet to horses 
weighing 800 to 1,300 lb once daily for up to 14 days.
    (ii) Indications for use. For the control of pain and inflammation 
associated with osteoarthritis.
    (iii) Limitations. Do not use in horses intended for human 
consumption. Federal law restricts this drug to use by or on the order 
of a licensed veterinarian.

Sec.  520.2345c  [Amended]

0
5. In Sec.  520.2345c, remove paragraph (d)(1)(iii).

PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

0
6. The authority citation for part 522 continues to read as follows:

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

0
7. Add Sec.  522.224 to read as follows:

Sec.  522.224  Bupivacaine.

    (a) Specifications. Each milliliter (mL) of liposomal suspension 
contains 13.3 milligrams (mg) bupivacaine.
    (b) Sponsor. See No. 086026 in Sec.  510.600(c) of this chapter.
    (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.
    (3) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.
0
8. In Sec.  522.1870, revise paragraphs (a), (c)(1)(i) and (iii), and 
(c)(2)(i) and (iii) to read as follows:

Sec.  522.1870  Praziquantel.

    (a) Specifications. Each milliliter (mL) of solution contains 56.8 
milligrams of praziquantel.
* * * * *
    (c) * * *
    (1) * * *
    (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.
* * * * *
    (iii) Limitations. Federal law restricts the drug to use by or on 
the order of a licensed veterinarian.
    (2) * * *
    (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.
* * * * *
    (iii) Limitations. Federal law restricts the drug to use by or on 
the order of a licensed veterinarian.
0
9. In Sec.  522.2630, revise paragraph (d)(1)(iii)(A) to read as 
follows:

Sec.  522.2630  Tulathromycin.

* * * * *
    (d) * * *
    (1) * * *
    (iii) * * *
    (A) Cattle intended for human consumption must not be slaughtered 
within 18 days from the last treatment. This drug is not approved for 
use in female dairy cattle 20 months of age or older, including dry 
dairy cows. Use in these cattle may cause drug residues in milk and/or 
in calves born to these cows. Federal law restricts this drug to use by 
or on the order of a licensed veterinarian.
* * * * *
0
10. Revise Sec.  522.2640 to read as follows:

Sec.  522.2640  Tylosin.

    (a) Specifications. Each milliliter (mL) of solution contains 50 or 
200 milligrams (mg) of tylosin activity (as tylosin base).
    (b) Sponsors. See sponsors in Sec.  510.600(c) of this chapter as 
follows:
    (1) No. 000986 for use of 50- or 200-mg/mL solutions as in 
paragraph (e) of this section.
    (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 Sec.  556.740 of this chapter.
    (d) Special considerations. Labeling must bear the warning 
statements: ``Do not administer to horses or other equines. Injection 
of tylosin in equines has been fatal.''
    (e) Conditions of use--(1) Beef cattle and nonlactating dairy 
cattle--(i) Amount. Administer 8 mg per pound (mg/lb) of body weight by 
intramuscular injection once daily for not more than 5 consecutive 
days. Continue treatment 24 hours after symptoms disappear.
    (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.

[[Page 67152]]

    (iii) Limitations. Do not inject more than 10 mL per site. Use a 
50-mg/mL solution for calves weighing less than 200 pounds. Cattle 
intended for human consumption must not be slaughtered within 21 days 
of the last use of this drug product. This drug product is not approved 
for use in female dairy cattle 20 months of age or older, including dry 
dairy cows. Use in these cattle may cause drug residues in milk and/or 
in calves born to these cows. This product is not approved for use in 
calves intended to be processed for veal. A withdrawal period has not 
been established in preruminating calves.
    (2) Swine--(i) Amount. Administer 4 mg/lb of body weight by 
intramuscular injection twice daily for not more than 3 consecutive 
days. Continue treatment 24 hours after symptoms disappear. If tylosin 
medicated drinking water is used as a followup treatment for swine 
dysentery, the animal should thereafter receive feed containing 40 to 
100 grams of tylosin per ton for 2 weeks to assure depletion of tissue 
residues.
    (ii) Indications for use. Treatment of swine arthritis caused by 
Mycoplasma hyosynoviae; swine pneumonia caused by Pasteurella spp.; 
swine erysipelas caused by Erysipelothrix rhusiopathiae; swine 
dysentery associated with Treponema hyodysenteriae when followed by 
appropriate medication in the drinking water and/or feed.
    (iii) Limitations. Do not inject more than 5 mL per site. Adverse 
reactions, including shock and death may result from overdosage in baby 
pigs. It is recommended that tylosin 50-mg/mL injection be used in pigs 
weighing less than 25 lbs. Swine intended for human consumption must 
not be slaughtered within 14 days of the last use of this drug product.
    (3) Dogs and cats--(i) Amount. Administer 3 to 5 mg/lb of body 
weight by intramuscular injection at 12- to 24-hour intervals.
    (ii) Indications for use--(A) Dogs. Treatment of upper respiratory 
infections such as bronchitis, tracheobronchitis, tracheitis, 
laryngitis, tonsillitis, and pneumonia caused by Staphylococci spp., 
hemolytic Streptococci spp., and Pasteurella multocida.
    (B) Cats. Treatment of upper respiratory infections when caused by 
Staphylococci spp. and hemolytic Streptococci spp. and for feline 
pneumonitis when caused by tylosin-susceptible organisms.
    (iii) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.

PART 524--OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS

0
11. The authority citation for part 524 continues to read as follows:

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

0
12. Add Sec.  524.998 to read as follows:

Sec.  524.998  Fluralaner.

    (a) Specifications. Each milliliter of solution contains 280 
milligrams (mg) fluralaner.
    (b) Sponsor. See No. 000061 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use--(1) Dogs--(i) Amount. Administer topically 
as a single dose every 12 weeks according to the label dosage schedule 
to provide a minimum dose of 11.4 mg/lb (25 mg/kg) body weight. May be 
administered every 8 weeks in case of potential exposure to Amblyomma 
americanum ticks.
    (ii) Indications for use. Kills adult fleas; for the treatment and 
prevention of flea infestations (Ctenocephalides felis) and the 
treatment and control of tick infestations (Ixodes scapularis (black-
legged tick), Dermacentor variabilis (American dog tick), and 
Rhipicephalus sanguineus (brown dog tick)) for 12 weeks in dogs and 
puppies 6 months of age and older, and weighing 4.4 lb or greater; for 
the treatment and control of A. americanum (lone star tick) 
infestations for 8 weeks in dogs and puppies 6 months of age and older, 
and weighing 4.4 lb or greater.
    (iii) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.
    (2) [Reserved]

PART 529--CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS

0
13. The authority citation for part 529 continues to read as follows:

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

Sec.  529.400  [Amended]

0
14. In Sec.  529.400, in paragraph (a), remove footnote 1.

PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS

0
15. The authority citation for part 558 continues to read as follows:

    Authority:  21 U.S.C. 354, 360b, 360ccc, 360ccc-1, 371.

Sec.  558.58  [Amended]

0
16. In Sec.  558.58, in paragraph (e)(6), remove ``3.6'' and in its 
place add ``36.6''.
0
17. Revise Sec.  558.59 to read as follows:

Sec.  558.59  Apramycin.

    (a) Specifications. Each pound of Type A article contains 75 grams 
apramycin (as apramycin sulfate).
    (b) Sponsor. See No. 058198 in Sec.  510.600(c) of this chapter.
    (c) [Reserved]
    (d) Related tolerances. See Sec.  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.

Sec.  558.68  [Amended]

0
18. In Sec.  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''.

Sec.  558.128  [Amended]

0
19. In Sec.  558.128, in paragraph (e)(7)(xi), remove ``Sec.  558.600'' 
and in its place add ''Sec.  558.612''.

Sec.  558.195  [Amended]

0
20. In Sec.  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''.

Sec.  558.261  [Amended]

0
21. In Sec.  558.261, redesignate paragraphs (c) and (d) as paragraphs 
(d) and (c).

Sec.  558.295  [Amended]

0
22. In Sec.  558.295, remove and reserve paragraph (b).
0
23. In Sec.  558.325, revise paragraph (d)(3) to read as follows:

Sec.  558.325  Lincomycin.

* * * * *
    (d) * * *
    (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.''
* * * * *

Sec.  558.342  [Amended]

0
24. In Sec.  558.342, in paragraphs (e)(1)(iv),(ix), (x), and (xi), 
remove

[[Page 67153]]

``000986'' wherever it appears and in its place add ``058198''.

Sec.  558.366  [Amended]

0
25. In Sec.  558.366, in paragraph (d), in the entry for ``113.5 
(0.0125 pct)'', remove ``000986'' and in its place add ``058198''.

Sec.  558.618  [Amended]

0
26. In Sec.  558.618, redesignate paragraphs (c) and (d) as paragraphs 
(d) and (c).
0
27. In Sec.  558.633, revise paragraph (d)(1) to read as follows:

Sec.  558.633  Tylvalocin.

* * * * *
    (d) * * *
    (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 Sec.  558.6 for additional requirements.
* * * * *

    Dated: September 21, 2016.
Tracey Forfa,
Deputy Director, Center for Veterinary Medicine.
[FR Doc. 2016-23230 Filed 9-29-16; 8:45 am]
 BILLING CODE 4164-01-P