Document ID: FDA-2014-N-0002-0066
Agency: fda
Document Type: Rule
Title: New Animal Drugs; Approval of New Animal Drug Applications; Change of Sponsor; Withdrawal of Approval of New Animal Drug Applications
Posted Date: 2014-12-15T05:00Z

[Federal Register Volume 79, Number 240 (Monday, December 15, 2014)]
[Unknown Section]
[Pages 74018-74021]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-29249]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510, 520, 522, and 558

[Docket No. FDA-2014-N-0002]

New Animal Drugs; Approval of New Animal Drug Applications; 
Change of Sponsor; Withdrawal of Approval of New Animal Drug 
Applications

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule, technical amendment.

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SUMMARY: The Food and Drug Administration (FDA) is amending the animal 
drug regulations to reflect approval actions for new animal drug 
applications (NADAs) and abbreviated new animal drug applications 
(ANADAs) during September and October 2014. 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 sponsorship 
of six NADAs and four ANADAs, the voluntary withdrawal of approval of 
an ANADA, and a correcting amendment.

DATES: This rule is effective December 15, 2014, except for the 
amendment to 21 CFR 520.1660d, which is effective December 26, 2014.

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 September and 
October 2014, 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.
    In addition, Lloyd, Inc., 604 W. Thomas Ave., Shenandoah, IA 51601, 
has transferred ownership of, and all rights and interest in, the 
following approved applications to Akorn Animal Health, Inc., 1925 West 
Field Ct., Suite 300, Lake Forest, IL 60045.

----------------------------------------------------------------------------------------------------------------
                   File No.                                       Product name                      21 CFR cite
----------------------------------------------------------------------------------------------------------------
139-236.......................................  ANASED (xylazine hydrochloride) Injectable              522.2662
                                                 Solution.
140-866.......................................  YOBINE (yohimbine hydrochloride) Injectable             522.2670
                                                 Solution.
140-994.......................................  TOLAZINE (tolazine hydrochloride) Injectable            522.2474
                                                 Solution.
200-055.......................................  VETAKET (ketamine hydrochloride) Injectable             522.1222
                                                 Solution.
200-332.......................................  BUTORPHIC (butorphanol tartrate) Injectable              522.246
                                                 Solution.
----------------------------------------------------------------------------------------------------------------

    Bioniche Animal Health USA, Inc., 119 Rowe Rd., Athens, GA 30601, 
has transferred ownership of, and all rights and interest in, the 
following approved applications to V[eacute]toquinol USA, Inc., 4250 N. 
Sylvania Ave., Fort Worth, TX 76137.

----------------------------------------------------------------------------------------------------------------
                   File No.                                       Product name                      21 CFR cite
----------------------------------------------------------------------------------------------------------------
141-431.......................................  FOLLTROPIN (follicle stimulating hormone)               522.1002
                                                 Injection.
200-266.......................................  BUTEQUINE (phenylbutazone) Paste................       520.1720c
200-432.......................................  NEXHA (hyaluronate sodium) Injection............        522.1145
----------------------------------------------------------------------------------------------------------------

[[Page 74019]]

    In addition, Veterinary Service, Inc. 4100 Bangs Ave., Modesto, CA 
95356, has transferred ownership of, and all rights and interest in, 
NADA 065-252 for STREP-SOL (streptomycin sulfate) Oral Solution to 
Huvepharma AD, 5th Floor, 3A Nikolay Haitov Str., 1113 Sofia, Bulgaria.
    Also, Elanco Animal Health, Inc., A Division of Eli Lilly & Co., 
Lilly Corporate Center, Indianapolis, IN 46285, has transferred 
ownership of, and all rights and interest in, NADA 141-272 for 
RECONCILE (fluoxetine hydrochloride) Chewable Tablets to Nexcyon 
Pharmaceuticals, Inc., 644 West Washington Ave., Madison, WI 53703.
    At this time, the regulations are being amended to reflect these 
changes of sponsorship. Following these changes of sponsorship, Akorn 
Animal Health, Inc., Nexcyon Pharmaceuticals, Inc., and 
V[eacute]toquinol USA, Inc. will now be the sponsors of an approved 
application while Bioniche Animal Health USA, Inc. and Veterinary 
Service, Inc. will no longer be the sponsors of an approved 
application. Accordingly, 21 CFR 510.600(c) is being amended to reflect 
these changes.
    FDA is also amending the regulations at 21 CFR 558.76 to remove a 
limitation on the concentrations of bacitracin methylene disalicyclate 
Type A medicated articles that can be used to manufacture medicated 
feed for quail. In addition, FDA is removing reserved 21 CFR 558.105 
for which there is no entry. These actions are being taken to improve 
the accuracy of the regulations.
    Also, V[eacute]toquinol N.-A., Inc., 2000 chemin Georges, Lavaltrie 
(PQ), Canada, J5T 3S5, has requested that FDA withdraw approval of 
ANADA 200-305 for Oxytetracycline Hydrochloride Soluble Powder because 
the product is no longer manufactured or marketed. Note this ANADA was 
identified as being 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.
    Elsewhere in this issue of the Federal Register, FDA gave notice 
that approval of ANADA 200-305, and all supplements and amendments 
thereto, is withdrawn, effective December 26, 2014. As provided in the 
regulatory text of this document, the animal drug regulations are 
amended to reflect this voluntary withdrawal of approval.
    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.

         Table 1--Original and Supplemental NADAs and ANADAs Approved During September and October 2014
----------------------------------------------------------------------------------------------------------------
                                   New animal drug                       21 CFR                           NEPA
   NADA/ ANADA        Sponsor        product name        Action         sections       FOIA summary      review
----------------------------------------------------------------------------------------------------------------
141-244.........  Zoetis Inc.,     DRAXXIN          Supplemental           522.2630  yes.............  CE1 2
                   333 Portage      (tulathromycin   approval for
                   St.,             ) Injectable     treatment of
                   Kalamazoo, MI    Solution.        bovine
                   49007.                            respiratory
                                                     disease (BRD)
                                                     in suckling
                                                     calves, dairy
                                                     calves, and
                                                     veal calves.
141-430x\3\.....  Phibro Animal    STAFAC           Original                558.355  yes.............  CE1 4
                   Health Corp.,    (virginiamycin   approval for
                   GlenPointe       ) plus COBAN     prevention of
                   Centre East,     (monensin)       coccidiosis
                   3d Floor, 300    combination      and necrotic
                   Frank W. Burr    drug Type C      enteritis in
                   Blvd., suite     medicated        broiler
                   21, Teaneck,     feeds.           chickens.
                   NJ 07666.
200-522.........  Putney, Inc.,    Carprofen        Original                522.304  yes.............  CE1 5
                   One Monument     Sterile          approval as a
                   Sq., suite       Injectable       generic copy
                   400, Portland,   Solution.        of NADA 141-
                   ME 04101.                         199.
200-540.........  Putney, Inc.,    Meloxicam        Original               522.1367  yes.............  CE1 5
                   One Monument     (meloxicam)      approval as a
                   Sq., suite       Solution for     generic copy
                   400, Portland,   Injection.       of NADA 141-
                   ME 04101.                         219.
200-581.........  Cross Vetpharm   FLUNAZINE        Original                520.970  yes.............  CE1 5
                   Group Ltd.,      (flunixin        approval as a
                   Broomhill Rd.,   meglumine)       generic copy
                   Tallaght,        Equine Paste.    of NADA 137-
                   Dublin 24,                        409.
                   Ireland.
----------------------------------------------------------------------------------------------------------------
\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)(5).
\3\ This application is affected by 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.
\4\ CE granted under 21 CFR 25.33(a)(2).
\5\ CE granted under 21 CFR 25.33(a)(1).

List of Subjects

21 CFR Part 510

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

21 CFR Parts 520 and 522

    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, 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. In Sec.  510.600, in the table in paragraph (c)(1), remove the 
entries for ``Bioniche Animal Health USA, Inc.'' and ``Veterinary 
Service, Inc.'' and

[[Page 74020]]

alphabetically add entries for ``Akorn Animal Health, Inc.'', ``Nexcyon 
Pharmaceuticals, Inc.'', and ``V[eacute]toquinol USA, Inc.''; and in 
the table in paragraph (c)(2), remove the entries for ``033008'' and 
``064847'' and numerically add entries for ``017030'', ``050929'', and 
``053599'' to 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
------------------------------------------------------------------------
 
                                * * * * *
Akorn Animal Health, Inc., 1925 West Field Ct., suite             053599
 300, Lake Forest, IL 60045.............................
 
                                * * * * *
Nexcyon Pharmaceuticals, Inc., 644 West Washington Ave.,          050929
 Madison, WI 53719......................................
 
                                * * * * *
V[eacute]toquinol USA, Inc., 4250 N. Sylvania Ave., Fort          017030
 Worth, TX 76137........................................
 
                                * * * * *
------------------------------------------------------------------------

    (2) * * *

------------------------------------------------------------------------
          Drug labeler code                  Firm name and address
------------------------------------------------------------------------
 
                                * * * * *
017030..............................  V[eacute]toquinol USA, Inc., 4250
                                       N. Sylvania Ave., Fort Worth, TX
                                       76137.
 
                                * * * * *
050929..............................  Nexcyon Pharmaceuticals, Inc., 644
                                       West Washington Ave., Madison, WI
                                       53719.
 
                                * * * * *
053599..............................  Akorn Animal Health, Inc., 1925
                                       West Field Ct., suite 300, Lake
                                       Forest, IL 60045.
 
                                * * * * *
------------------------------------------------------------------------

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.  520.970, revise paragraphs (b) and (c)(1) to read as 
follows:

Sec.  520.970  Flunixin.

* * * * *
    (b) Sponsors. See sponsors in Sec.  510.600(c) of this chapter for 
use as in paragraph (c) of this section.
    (1) No. 000061 for use of products described in paragraph (a).
    (2) No. 061623 for use of the product described in paragraph 
(a)(2).
    (c) * * *
    (1) Amount. 0.5 mg per pound of body weight per day for up to 5 
days.
* * * * *

Sec.  520.980  [Amended]

    5. In paragraph (b) of Sec.  520.980, remove ``000986'' and in its 
place add ``050929''.

Sec.  520.1660d  [Amended]

0
6. In Sec.  520.1660d, remove paragraph (b)(8); and in paragraphs 
(d)(1)(ii)(A)(3), (d)(1)(ii)(B)(3), (d)(1)(ii)(C)(3), and 
(d)(1)(iii)(C), remove ``059320,''.

Sec.  520.1720c  [Amended]

0
7. In paragraph (b)(2) of Sec.  520.1720c, remove ``064847'' and in its 
place add ``017030''.

Sec.  520.2158  [Amended]

0
8. In paragraph (b) of Sec.  520.2158, remove ``033008'' and in its 
place add ``016592''.

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

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

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

Sec.  522.246  [Amended]

0
10. In paragraph (b)(3) of Sec.  522.246, remove ``061690'' and in its 
place add ``053599''.

0
11. In Sec.  522.304, revise paragraph (b) to read as follows:

Sec.  522.304  Carprofen.

* * * * *
    (b) Sponsors. See Nos. 026637, 054771, and 055529 in Sec.  
510.600(c) of this chapter.
* * * * *

Sec.  522.1002  [Amended]

0
12. In paragraph (c)(2) of Sec.  522.1002, remove ``064847'' and in its 
place add ``017030''.

Sec.  522.1145  [Amended]

0
13. In paragraph (e)(2)(ii) of Sec.  522.1145, remove ``064847'' and in 
its place add ``017030''.

0
14. In Sec.  522.1222, revise paragraph (b) to read as follows:

Sec.  522.1222  Ketamine.

* * * * *
    (b) Sponsors. See Nos. 000859, 026637, 053599, 054628, 054771, and 
063286 in Sec.  510.600(c) of this chapter.
* * * * *

0
15. In Sec.  522.1367, revise paragraph (b) to read as follows:

Sec.  522.1367  Meloxicam.

* * * * *
    (b) Sponsors. See Nos. 000010, 016729, 026637, and 055529 in Sec.  
510.600(c) of this chapter.
* * * * *

Sec.  522.2474  [Amended]

0
16. In paragraph (b) of Sec.  522.2474, remove ``061690'' and in its 
place add ``053599''.

0
17. In Sec.  522.2630, revise paragraph (d)(1) to read as follows:

Sec.  522.2630  Tulathromycin.

* * * * *
    (d) * * *
    (1) Cattle--(i) Amount. 2.5 mg per kilogram (/kg) body weight as a 
single subcutaneous injection in the neck.
    (ii) Indications for use--(A) Beef and non-lactating dairy cattle; 
suckling calves, dairy calves, and veal calves: For the treatment of 
bovine respiratory disease (BRD) associated with Mannheimia 
haemolytica, Pasteurella multocida, Histophilus somni, and Mycoplasma 
bovis;
    (B) Beef and non-lactating dairy cattle: For the control of 
respiratory disease in cattle at high risk of developing BRD associated 
with M. haemolytica, P. multocida, H. somni, and M. bovis. For the 
treatment of infectious bovine keratoconjunctivitis associated with 
Moraxella bovis. For the treatment of bovine foot rot (interdigital 
necrobacillosis) associated with Fusobacterium necrophorum and 
Porphyromonas levii.
    (iii) Limitations. Cattle intended for human consumption must not 
be slaughtered within 18 days from the last treatment. Do not use in 
female dairy cattle 20 months of age or older. Federal law restricts 
this drug to use by or on the order of a licensed veterinarian.
* * * * *

Sec.  522.2662  [Amended]

0
18. In paragraph (b)(4) of Sec.  522.2662, remove ``061690'' and in its 
place add ``053599''.

0
19. Revise Sec.  522.2670 to read as follows:

Sec.  522.2670  Yohimbine.

    (a) Specifications. Each milliliter (mL) of solution contains 2 or 
5 milligrams (mg) of yohimbine (as hydrochloride).

[[Page 74021]]

    (b) Sponsors. See sponsors in Sec.  510.600(c) of this chapter for 
use as in paragraph (c) of this section.
    (1) No. 053599 for use of in 2 mg/mL solution as in paragraph 
(c)(1) of this section.
    (2) No. 053923 for use of in 5 mg/mL solution as in paragraph 
(c)(2) of this section.
    (c) Conditions of use--(1) Dogs--(i) Amount. Administer 0.05 mg per 
pound (0.11 mg per kilogram) of body weight by intravenous injection.
    (ii) Indications for use. To reverse the effects of xylazine in 
dogs.
    (iii) Limitations. Not for use in food-producing animals. Federal 
law restricts this drug to use by or on the order of a licensed 
veterinarian.
    (2) Deer and elk--(i) Amount. Administer 0.2 to 0.3 mg per kilogram 
of body weight by intravenous injection.
    (ii) Indications for use. A s an antagonist to xylazine sedation in 
free ranging or confined members of the family Cervidae (deer and elk).
    (iii) Limitations. Do not use in domestic food-producing animals. 
Do not use for 30 days before or during hunting season. Federal law 
restricts this drug to use by or on the order of a licensed 
veterinarian.

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

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

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

Sec.  558.76  [Amended]

0
21. In Sec.  558.76, in paragraph (d)(1)(x), in the entry for 
``Quail'', in the ``Limitations'' column, remove the first sentence.

Sec.  558.105  [Removed]

0
22. Remove reserved Sec.  558.105.

0
23. In Sec.  558.355, add paragraph (f)(1)(xxxi) to read as follows:

Sec.  558.355  Monensin.

* * * * *
    (f) * * *
    (1) * * *
    (xxxi) Amount per ton. Monensin, 90 to 110 grams; plus 
virginiamycin, 20 grams.
    (a) Indications for use. Broiler chickens: As an aid in the 
prevention of coccidiosis caused by E. necatrix, E. tenella, E. 
acervulina, E. brunetti, E. mivati, and E. maxima; and for prevention 
of necrotic enteritis caused by Clostridium perfringens susceptible to 
virginiamycin.
    (b) Limitations. Feed continuously as sole ration. Do not feed to 
laying chickens. See paragraph (d) of this section. As monensin 
provided by No. 000986; virginiamycin as provided by No. 066104 in 
Sec.  510.600(c) of this chapter.
* * * * *

    Dated: December 9, 2014.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2014-29249 Filed 12-12-14; 8:45 am]
BILLING CODE 4164-01-P