Document ID: FDA-2015-N-0002-0001
Agency: fda
Document Type: Rule
Title: New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Change of Sponsor; Change of Sponsor’s Name; Change of Sponsor’s Address
Posted Date: 2015-04-08T04:00Z

[Federal Register Volume 80, Number 67 (Wednesday, April 8, 2015)]
[Rules and Regulations]
[Pages 18773-18777]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-08025]

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 Rules and Regulations
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  Federal Register / Vol. 80, No. 67 / Wednesday, April 8, 2015 / Rules 
and Regulations  

[[Page 18773]]

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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

[Docket No. FDA-2015-N-0002]

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

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; technical amendments.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) 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 January and February 2015. 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 several non-substantive 
changes. These technical amendments are being made to improve the 
accuracy of the regulations.

DATES: This rule is effective April 8, 2015, except for the amendment 
to 21 CFR 522.1004, which is effective April 20, 2015.

FOR FURTHER INFORMATION CONTACT: 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.

SUPPLEMENTARY INFORMATION: FDA is amending the animal drug regulations 
to reflect approval actions for NADAs and ANADAs during January and 
February 2015, 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 January and February 2015
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                     New animal drug                                21 CFR
       NADA/ANADA                Sponsor              product name               Action            sections           FOIA summary          NEPA review
--------------------------------------------------------------------------------------------------------------------------------------------------------
141-435................  Piedmont Animal         ADVANTUS                Original approval for        520.1156  yes.....................          CE 1 2
                          Health, 204 Muirs       (imidacloprid)          the treatment of
                          Chapel Rd., Suite       Chewable Tablets.       flea infestations on
                          200, Greensboro, NC                             dogs and puppies.
                          27410.
141-418................  Luitpold                BETAVET (betamethasone  Original approval for         522.167  yes.....................          CE 1 2
                          Pharmaceuticals,        sodium phosphate and    the control of pain
                          Inc., Animal Health     betamethasone           and inflammation
                          Division, Shirley, NY   acetate) Injectable     associated with
                          11967.                  Suspension.             osteoarthritis in
                                                                          horses.
200-527................  Putney, Inc., One       Enrofloxacin            Original approval as          522.812  yes.....................          CE 1 3
                          Monument Sq., suite     Antibacterial           a generic copy of
                          400, Portland, ME       Injectable Solution.    NADA 140-913.
                          04101.
200-576................  Akorn Animal Health,    Gentamicin Sulfate      Original approval as        524.1044a  yes.....................          CE 1 3
                          Inc., 1925 West Field   Ophthalmic Solution.    a generic copy of
                          Ct., suite 300, Lake                            NADA 099-008.
                          Forest, IL 60045.

[[Page 18774]]

 
141-280 \4\............  Intervet, Inc., 556     ZILMAX (zilpaterol      Supplemental approval         558.665  yes.....................          CE 1 5
                          Morris Ave., Summit,    hydrochloride) plus     to provide for
                          NJ 07901.               RUMENSIN (monensin)     component feeding of
                                                  plus TYLAN (tylosin     combination drug
                                                  phosphate) plus MGA     Type C medicated
                                                  (melengestrol           feeds to heifers fed
                                                  acetate) Type A         in confinement for
                                                  medicated articles.     slaughter.
141-406................  Merial, Inc., 3239      NEXGARD (afoxolaner)    Supplemental approval          520.43  yes.....................          CE 1 2
                          Satellite Blvd.,        Chewable Tablets.       for the treatment
                          Bldg. 500, Duluth, GA                           and control of an
                          30096-4640.                                     additional tick
                                                                          species in dogs and
                                                                          puppies.
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ The Agency has determined that this action is categorically excluded (CE) from the requirement to submit an environmental assessment or an
  environmental impact statement because it is of a type that does not have a significant effect on the human environment.
\2\ CE granted under 21 CFR 25.33(d)(1).
\3\ CE granted under 21 CFR 25.33(a)(1).
\4\ This application is affected by guidance for industry (GFI) #213, ``New Animal Drugs and New Animal Drug Combination Products Administered in or on
  Medicated Feed or Drinking Water of Food-Producing Animals: Recommendations for Drug Sponsors for Voluntarily Aligning Product Use Conditions with GFI
  #209'', December 2013.
\5\ CE granted under 21 CFR 25.33(a)(2).

    In addition during January and February 2015, ownership of, and all 
rights and interest in, the following approved applications have been 
transferred as follows:

 
----------------------------------------------------------------------------------------------------------------
                                                      New animal drug
       NADA/ANADA            Previous sponsor          product name             New sponsor       21 CFR Section
----------------------------------------------------------------------------------------------------------------
141-098.................  Abbott Laboratories,    PROPOFLO (propofol)     Zoetis Inc., 333              522.2005
                           North Chicago, IL       Injectable Suspension.  Portage St.,
                           60064.                                          Kalamazoo, MI 49007.
141-103.................  Abbott Laboratories,    SEVOFLO (sevoflurane)   Zoetis Inc., 333              529.2150
                           North Chicago, IL       Inhalation Anesthetic.  Portage St.,
                           60064.                                          Kalamazoo, MI 49007.
141-346.................  Abbott Laboratories,    OROCAM (meloxicam)      Zoetis Inc., 333              529.1350
                           North Chicago, IL       Oral Spray.             Portage St.,
                           60064.                                          Kalamazoo, MI 49007.
141-434.................  Abbott Laboratories,    SIMBADOL                Zoetis Inc., 333               522.230
                           North Chicago, IL       (buprenorphine)         Portage St.,
                           60064.                  Injectable Solution.    Kalamazoo, MI 49007.
200-070.................  Abbott Laboratories,    ISOFLO (isoflurane)     Zoetis Inc., 333              529.1186
                           North Chicago, IL       Inhalation Anesthetic.  Portage St.,
                           60064.                                          Kalamazoo, MI 49007.
048-480.................  ADM Alliance            CHLORATET 90 and 100    Pharmgate LLC, 161             558.128
                           Nutrition., Inc.,       (chlortetracycline)     North Franklin
                           1000 North 30th St.,    Type A medicated        Turnpike, suite 2C,
                           Quincy, IL 62305-3115.  articles.               Ramsey, NJ 07446.
065-256.................  ADM Alliance            CHLORTET-SOLUBLE-O      Pharmgate LLC, 161             520.441
                           Nutrition., Inc.,       (chlortetracycline)     North Franklin
                           1000 North 30th St.,    Powder.                 Turnpike, suite 2C,
                           Quincy, IL 62305-3115.                          Ramsey, NJ 07446.
200-197.................  Contemporary Products,  Streptomycin Oral       Huvepharma AD, 5th            520.2158
                           Inc., 3788 Elm          Solution.               Floor, 3A Nikolay
                           Springs Rd.,                                    Haitov Str., 1113
                           Springdale, AR 72764-                           Sofia, Bulgaria.
                           6067.
141-084.................  Novartis Animal Health  SENTINEL (milbemycin    Virbac AH, Inc., 3200         522.1143
                           US, Inc., 3200          oxime and lufenuron)    Meacham Blvd., Ft.
                           Northline Ave., suite   FLAVOR TABS.            Worth, TX 76137.
                           300, Greensboro, NC
                           27408.
141-204.................  Novartis Animal Health  SENTINEL (milbemycin    Virbac AH, Inc., 3200         520.1510
                           US, Inc., 3200          oxime and lufenuron)    Meacham Blvd., Ft.
                           Northline Ave., suite   FLAVOR TABS and         Worth, TX 76137.
                           300, Greensboro, NC     CAPSTAR (nitenpyram)
                           27408.                  Tablets Flea
                                                   Management Program.
141-333.................  Novartis Animal Health  SENTINEL SPECTRUM       Virbac AH, Inc., 3200         520.1447
                           US, Inc., 3200          (milbemycin oxime/      Meacham Blvd., Ft.
                           Northline Ave., suite   lufenuron/              Worth, TX 76137.
                           300, Greensboro, NC     praziquantel) Tablets.
                           27408.
141-067.................  OPK Biotech, LLC, 11    OXYGLOBIN (hemoglobin   Hemoglobin Oxygen             522.1125
                           and 39 Hurley St.,      glutamer-200            Therapeutics, LLC,
                           Cambridge, MA.          (bovine)).              674 Souder Rd.,
                                                                           Souderton, PA 18964.
----------------------------------------------------------------------------------------------------------------

[[Page 18775]]

    At this time, the regulations are being amended to reflect these 
changes of sponsorship.
    In addition, Paladin Labs (USA), Inc., 160 Greentree Dr., Suite 
101, Dover, DE 19904 has requested that FDA withdraw approval of NADA 
141-075 for ANTIZOL-VET (fomepizole) Injection. Elsewhere in this issue 
of the Federal Register, FDA gave notice that approval of NADA 141-075, 
and all supplements and amendments thereto, is withdrawn, effective 
April 20, 2015. As provided in the regulatory text of this document, 
the animal drug regulations are being amended to reflect this voluntary 
withdrawal of approval.
    Following these changes of sponsorship and withdrawal of approval, 
Hemoglobin Oxygen Therapeutics, LLC is now the sponsor of an approved 
application while OPK Biotech, LLC and Paladin Labs (USA), Inc., are no 
longer the sponsor of an approved application. Also, Merial Ltd., 3239 
Satellite Blvd., Bldg. 500, Duluth, GA 30096-4640, has informed FDA 
that it has changed its name to Merial, Inc., and Intervet, Inc., 556 
Morris Ave., Summit, NJ 07901, has informed FDA that it has changed its 
address to 2 Giralda Farms, Madison, NJ 07940. Accordingly, Sec.  
510.600 (21 CFR 510.600) is being amended to reflect these changes.
    In addition, FDA is amending the tables in Sec.  510.600(c) to 
remove listings for International Nutrition, Inc.; NutriBasics Co.; 
Seeco Inc.; Southern Micro-Blenders, Inc.; and Wellmark International 
because these firms are no longer the sponsor of an approved 
application. These technical amendments are being made to improve the 
accuracy 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.

    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 21 CFR part 510 continues to read as 
follows:

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

0
2. Amend Sec.  510.600 as follows:
0
a. In the table in paragraph (c)(1), remove the entries for 
``Contemporary Products, Inc.'', ``International Nutrition, Inc.'', 
``NutriBasics Co.'', ``OPK Biotech, LLC'', ``Paladin Labs (USA), 
Inc.'', ``Seeco Inc.'', ``Southern Micro-Blenders, Inc.'', and 
``Wellmark International'';
0
b. In the table in paragraph (c)(1), revise the entries for ``Intervet, 
Inc.'' and ``Merial Ltd.''; and add an entry, in alphabetical order, 
for ``Hemoglobin Oxygen Therapeutics, LLC'';
0
c. In the table in paragraph (c)(2), remove the entries for ``011536'', 
``043733'', ``046129'', and ``055462''; and
0
d. In the table in paragraph (c)(2), revise the entries for ``000061'', 
``050604'', and ``063075''.
    The additions and revisions read as follows:

Sec.  510.600  Names, addresses, and drug labeler codes of sponsors of 
approved applications.

* * * * *
    (c) * * *
    (1) * * *

------------------------------------------------------------------------
                                                           Drug labeler
                  Firm name and address                        code
------------------------------------------------------------------------
 
                                * * * * *
Hemoglobin Oxygen Therapeutics, LLC, 674 Souder Rd.,              063075
 Souderton, PA 18964....................................
 
                                * * * * *
Intervet, Inc., 2 Giralda Farms, Madison, NJ 07940......          000061
 
                                * * * * *
Merial, Inc., 3239 Satellite Blvd., Bldg. 500, Duluth,            050604
 GA 30096-4640..........................................
 
                                * * * * *
------------------------------------------------------------------------

    (2) * * *

------------------------------------------------------------------------
          Drug labeler code                  Firm name and address
------------------------------------------------------------------------
 
                                * * * * *
000061..............................  Intervet, Inc., 2 Giralda Farms,
                                       Madison, NJ 07940.
 
                                * * * * *
050604..............................  Merial, Inc., 3239 Satellite
                                       Blvd., Bldg. 500, Duluth, GA
                                       30096-4640.
 
                                * * * * *
063075..............................  Hemoglobin Oxygen Therapeutics,
                                       LLC, 674 Souder Rd., Souderton,
                                       PA 18964.
 
                                * * * * *
------------------------------------------------------------------------

PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS

0
 3. The authority citation for 21 CFR part 520 continues to read as 
follows:

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

0
4. In Sec.  520.43, revise paragraph (c)(2) to read as follows:

Sec.  520.43  Afoxolaner.

* * * * *
    (c) * * *
    (2) Indications for use. Kills adult fleas; for the treatment and 
prevention of flea infestations (Ctenocephalides felis); for the 
treatment and control of black-legged tick (Ixodes scapularis), 
American dog tick (Dermacentor variabilis), lone star tick (Amblyomma 
americanum), and brown dog tick (Rhipicephalus sanguineus) infestations 
in dogs and puppies 8 weeks of age and older, weighing 4 lb of body 
weight or greater, for 1 month.
* * * * *

Sec.  520.441  [Amended]

0
5. In Sec.  520.441, in paragraph (b)(4), remove ``012286'' and in its 
place add ``069254''.

0
6. Add Sec.  520.1156 to read as follows:

Sec.  520.1156  Imidacloprid.

    (a) Specifications. Each chewable tablet contains 7.5 or 37.5 
milligrams (mg) imidacloprid.
    (b) Sponsor. See No. 000859 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use in dogs--(1) Amount. Administer daily one 
7.5-mg chewable tablet to dogs weighing 4 to 22 pounds (lb) or one 
37.5-mg chewable table to dogs weighing 23 to 110 lb.
    (2) Indications for use. Kills adult fleas and is indicated for the 
treatment of flea infestations on dogs and puppies 10 weeks of age and 
older and weighing 4 lb or greater.
    (3) Limitations. Do not give to puppies younger than 10 weeks of 
age or to dogs weighing less than 4 lb. Do not give more than one 
tablet a day.

[[Page 18776]]

Sec.  520.1443  [Amended]

0
7. In Sec.  520.1443, in paragraph (b), remove ``058198'' and in its 
place add ``051311''.

Sec.  520.1447  [Amended]

0
8. In Sec.  520.1447, in paragraph (b), remove ``058198'' and in its 
place add ``051311''.
0
9. In Sec.  520.1510, in paragraph (d)(1)(ii)(B), remove ``Sec.  
520.1446(d)(1) of this chapter'' and in its place add ``Sec.  
520.1443(d)(1)''; and revise the section heading and paragraph (b) to 
read as follows:

Sec.  520.1510  Nitenpyram.

* * * * *
    (b) Sponsors. See sponsor numbers in Sec.  510.600(c) of this 
chapter:
    (1) No. 058198 for use as in paragraphs (d)(1)(i)(A), 
(d)(1)(ii)(A), and (d)(2) of this section.
    (2) No. 051311 for use as in paragraphs (d)(1)(i)(B) and 
(d)(1)(ii)(B) of this section.
* * * * *

Sec.  520.2158  [Amended]

0
10. In Sec.  520.2158, in paragraph (b), remove ``Nos. 016592 and 
055462'' and in its place add ``No. 016592''.

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

0
11. The authority citation for 21 CFR part 522 continues to read as 
follows:

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

0
12. Add Sec.  522.167 to read as follows:

Sec.  522.167  Betamethasone sodium phosphate and betamethasone 
acetate.

    (a) Specifications. Each milliliter (mL) of suspension contains 6 
milligrams (mg) betamethasone (3.15 mg betamethasone sodium phosphate 
and 2.85 mg betamethasone acetate).
    (b) Sponsor. See No. 010797 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use in horses--(1) Amount. Administer 1.5 mL (9 
mg total betamethasone) per joint by intra-articular injection. May be 
administered concurrently in up to two joints per horse.
    (2) Indications for use. For the control of pain and inflammation 
associated with osteoarthritis in horses.
    (3) 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.  522.230  [Amended]

0
13. In Sec.  522.230, in paragraph (b), remove ``000044'' and in its 
place add ``054771''.
0
14. In Sec.  522.812, add paragraph (b)(3) to read as follows:

Sec.  522.812  Enrofloxacin.

* * * * *
    (b) * * *
    (3) No. 026637 for use of product described in paragraph (a)(1) as 
in paragraph (e)(1) of this section.
* * * * *

Sec.  522.1004  [Removed]

0
15. Remove Sec.  522.1004.

0
16. In Sec.  522.2005, remove paragraph (b)(3); and revise paragraph 
(b)(2) to read as follows:

Sec.  522.2005  Propofol.

* * * * *
    (b) * * *
    (2) No. 054771 for use as in paragraph (c) of this section.
* * * * *

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

0
17. The authority citation for 21 CFR part 524 continues to read as 
follows:

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

0
18. Revise Sec.  524.1044a to read as follows:

Sec.  524.1044a  Gentamicin ophthalmic solution.

    (a) Specifications. Each milliliter of solution contains gentamicin 
sulfate equivalent to 3 milligrams of gentamicin.
    (b) Sponsors. See Nos. 000061 and 059399 in Sec.  510.600(c) of 
this chapter.
    (c) Conditions of use in dogs and cats--(1) Amount. Administer 1 or 
2 drops into the conjunctival sac 2 to 4 times a day.
    (2) Indications for use. For the topical treatment of infections of 
the conjunctiva caused by susceptible bacteria.
    (3) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.

PART 529--CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS

0
19. The authority citation for 21 CFR part 529 continues to read as 
follows:

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

Sec.  529.1186  [Amended]

0
20. In Sec.  529.1186, in paragraph (b), remove ``000044'' and add 
``054771,'' after ``012164,''.

Sec.  529.1350  [Amended]

0
21. In Sec.  529.1350, in paragraph (b), remove ``000074'' and in its 
place add ``054771''.

Sec.  529.2150  [Amended]

0
22. In Sec.  529.2150, in paragraph (b), remove ``000044'' and add 
``054771,'' after ``012164,''.

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

0
23. The authority citation for 21 CFR part 558 continues to read as 
follows:

    Authority: 21 U.S.C. 360b, 371.

Sec.  558.128  [Amended]

0
24. Amend Sec.  558.128 as follows:
0
a. In paragraph (b)(2), remove ``No. 012286'' and in its place add 
``No. 069254'';
0
b. In paragraph (e)(3)(iv), in the ``Limitations'' column, remove 
``012286'' and in its place add ``069254''; and
0
c. In the tables in paragraphs (e)(1), (e)(2), (e)(3), and (e)(4), in 
the ``Sponsor'' column, remove ``012286,'' wherever it occurs.

0
25. In Sec.  558.665, add paragraph (e)(9) to read as follows:

Sec.  558.665  Zilpaterol.

* * * * *
    (e) * * *

[[Page 18777]]

----------------------------------------------------------------------------------------------------------------
                                      Combination in
     Zilpaterol in grams/ton            grams/ton       Indications for use      Limitations          Sponsor
----------------------------------------------------------------------------------------------------------------
 
                                                  * * * * * * *
(9) 6.8 to 24....................  Monensin 10 to 40,   Heifers fed in       Feed continuously            000061
                                    plus tylosin 8 to    confinement for      to heifers during
                                    10, plus             slaughter: For       the last 20 to 40
                                    melengestrol         increased rate of    days on feed to
                                    acetate to provide   weight gain,         provide 60 mg
                                    0.25 to 0.5 mg/      improved feed        zilpaterol
                                    head/day.            efficiency, and      hydrochloride per
                                                         increased carcass    head per day. See
                                                         leanness in cattle   Sec.  Sec.
                                                         fed in confinement   558.342(d),
                                                         for slaughter        558.355(d), and
                                                         during the last 20   558.625(c).
                                                         to 40 days on        Monensin and
                                                         feed; for            tylosin as
                                                         prevention and       provided by No.
                                                         control of           000986;
                                                         coccidiosis due to   melengestrol
                                                         Eimeria bovis and    acetate as
                                                         E. zuernii; and      provided by No.
                                                         for reduction of     054771 in Sec.
                                                         incidence of liver   510.600(c) of this
                                                         abscesses caused     chapter.
                                                         by Fusobacterium     Withdrawal period:
                                                         necrophorum and      3 days.
                                                         Arcanobacterium
                                                         (Actinomyces)
                                                         pyogenes; and for
                                                         suppression of
                                                         estrus (heat).
----------------------------------------------------------------------------------------------------------------

    Dated: April 3, 2015.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2015-08025 Filed 4-7-15; 8:45 am]
 BILLING CODE 4164-01-P