Document ID: FDA-2016-N-0002-0040
Agency: fda
Document Type: Rule
Title: New Animal Drugs: Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Application; Change of Sponsor; Change of Sponsor's Name
Posted Date: 2017-03-01T05:00Z

[Federal Register Volume 82, Number 39 (Wednesday, March 1, 2017)]
[Rules and Regulations]
[Pages 12167-12170]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-03930]

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 Rules and Regulations
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  Federal Register / Vol. 82, No. 39 / Wednesday, March 1, 2017 / Rules 
and Regulations  

[[Page 12167]]

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510, 516, 520, 522, 529, and 558

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

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

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; technical amendment.

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

SUMMARY: The Food and Drug Administration (FDA or 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 November and December 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 the change of 
sponsorship of an application and a change of a sponsor's name.

DATES: This rule is effective March 1, 2017, except for amendments 2.a 
and 2.c to 21 CFR 510.600, and the amendments to 21 CFR 522.313c and 
529.1186, which are effective March 13, 2017.

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 November and December 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 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 November and December 2016
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                  Effect of the
         Approval date              File No.            Sponsor            Product name          Species              action          Public  documents
--------------------------------------------------------------------------------------------------------------------------------------------------------
November 10, 2016..............         141-474  Elanco US, Inc.,      ITRAFUNGOL           Cats.............  Original approval    FOI Summary.
                                                  2500 Innovation       (itraconazole oral                      for the treatment
                                                  Way, Greenfield, IN   solution).                              of dermatophytosis
                                                  46140.                                                        caused by
                                                                                                                Microsporum canis
                                                                                                                in cats.
November 16, 2016..............         141-443  Elanco US Inc., 2500  ONSIOR               Dogs.............  Supplemental         FOI Summary.
                                                  Innovation Way,       (robenacoxib)                           approval for the
                                                  Greenfield, IN        Injection.                              control of
                                                  46140.                                                        postoperative pain
                                                                                                                and inflammation
                                                                                                                associated with
                                                                                                                soft tissue
                                                                                                                surgery in dogs by
                                                                                                                subcutaneous
                                                                                                                injection; and for
                                                                                                                the use of oral
                                                                                                                tablets to
                                                                                                                complete the
                                                                                                                dosing regimen of
                                                                                                                a maximum of 3
                                                                                                                days.
December 12, 2016..............         141-452  Zoetis Inc., 333      SIMPARICA            Dogs.............  Supplemental         FOI Summary.
                                                  Portage St.,          (sarolaner)                             approval for the
                                                  Kalamazoo, MI 49007.  Chewables.                              treatment and
                                                                                                                control of
                                                                                                                infestations of
                                                                                                                Ixodes scapularis
                                                                                                                (black-legged
                                                                                                                tick) in dogs.

[[Page 12168]]

 
December 16, 2016..............         141-473  Huvepharma AD, 5th    LINCOMIX             Chickens.........  Original approval    FOI Summary.
                                                  Floor, 3A Nikolay     (lincomycin                             for use in two-
                                                  Haytov Str., 1113     phosphate) plus                         way, combination
                                                  Sophia, Bulgaria.     STENOROL                                drug Type C
                                                                        (halofuginone                           medicated broiler
                                                                        hydrobromide) Type                      feeds for control
                                                                        C medicated feeds.                      of necrotic
                                                                                                                enteritis and
                                                                                                                prevention of
                                                                                                                coccidiosis in
                                                                                                                broiler chickens.
December 21, 2016..............         200-589  Med-Pharmex, Inc.,    FLORCON              Swine............  Original approval    FOI Summary.
                                                  2727 Thompson Creek   (florfenicol) 2.3%                      of a generic copy
                                                  Rd., Pomona, CA       Concentrate                             of NADA 141-206.
                                                  91767-1861.           Solution.
December 29, 2016..............         141-475  VetDC, Inc., 320 E.   TANOVEA-CA1          Dogs.............  Conditional          FOI Summary.
                                                  Vine Dr., Suite       (rabacfosadine for                      approval for the
                                                  218, Fort Collins,    injection).                             treatment of
                                                  CO 80524.                                                     lymphoma in dogs.
--------------------------------------------------------------------------------------------------------------------------------------------------------

    Following the conditional approval of NADA 141-175, VetDC, Inc. 
will now be included in the list of sponsors of approved applications 
in Sec.  510.600(c) (21 CFR 510.600(c)).

II. Change of Sponsorship

    ECO LLC, 344 Nassau St., Princeton, NJ 08540 has informed FDA that 
it has transferred ownership of, and all rights and interest in, ANADA 
200-600 for WORMX (pyrantel pamoate) Flavored Tablets to Sergeant's Pet 
Care Products, Inc., 10077 S. 134th St., Omaha, NE 68138. The 
regulations will be amended to reflect this change of sponsorship.

III. Withdrawals of Approval

    During November and December 2016, 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:

----------------------------------------------------------------------------------------------------------------
                                                                                                      21 CFR
                File No.                            Sponsor                  Product name             section
----------------------------------------------------------------------------------------------------------------
135-773.................................  Baxter Healthcare Corp.,    AERRANE (isoflurane USP)..        529.1186
                                           One Baxter Pkwy.,
                                           Deerfield, IL 60015.
200-421.................................  Hospira, Inc., 275 North    Ceftiofur (ceftiofur              522.313c
                                           Field Dr., Lake Forest,     sodium) for Injection.
                                           IL 60045.
----------------------------------------------------------------------------------------------------------------

    Elsewhere in this issue of the Federal Register, FDA gave notice 
that approval of NADA 135-773 and ANADA 200-524, and all supplements 
and amendments thereto, is withdrawn, effective March 13, 2017. As 
provided in the regulatory text of this document, the animal drug 
regulations are amended to reflect this voluntary withdrawal of 
approval. Following this withdrawal of approval, neither Baxter 
Healthcare Corp. nor Hospira, Inc. is the sponsor of an approved 
application.
    IV. Technical Amendments
    iVaoes Animal Health, 4300 SW 73rd Ave., Suite 110, Miami, FL 33155 
has informed FDA that it has changed its name to Ivaoes Animal Health. 
Accordingly, we are amending Sec.  510.600 (c) to reflect this change 
of sponsor name. We are also making several technical amendments 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 Part 516

    Administrative practice and procedure, Animal drugs, Confidential 
business information, Reporting and recordkeeping requirements.

21 CFR Parts 520, 522, 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, 
516, 520, 522, 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.

0
2. Amend Sec.  510.600 as follows:
0
a. Effective March 13, 2017, in the table in paragraph (c)(1), remove 
the entries for ``Baxter Healthcare Corp.'' and ``Hospira, Inc.'';
0
b. Effective March 1, 2017, in the table in paragraph (c)(1), revise 
the entry for ``iVaoes Animal Health'' and alphabetically add an entry 
for ``VetDC, Inc.'';
0
c. Effective March 13, 2017, in the table in paragraph (c)(2), remove 
the entries for ``000409'' and ``010019''; and
0
d. Effective March 1, 2017, in the table in paragraph (c)(2), revise 
the entry for ``086064'' and numerically add an entry for ``086072''.

[[Page 12169]]

    The revisions and additions 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
------------------------------------------------------------------------
 
                              * * * * * * *
Ivaoes Animal Health, 4300 SW 73rd Ave., Suite 110,               086064
 Miami, FL 33155........................................
 
                              * * * * * * *
VetDC, Inc., 320 E. Vine Dr., Suite 218, Fort Collins,            086072
 CO 80524...............................................
 
                              * * * * * * *
------------------------------------------------------------------------

    (2) * * *

------------------------------------------------------------------------
      Drug labeler code                  Firm name and address
------------------------------------------------------------------------
 
                              * * * * * * *
086064......................  Ivaoes Animal Health, 4300 SW 73rd Ave.,
                               Suite 110, Miami, FL 33155.
 
                              * * * * * * *
086072......................  VetDC, Inc., 320 E Vine Dr., Suite 218,
                               Fort Collins, CO 80524.
 
                              * * * * * * *
------------------------------------------------------------------------

PART 516--NEW ANIMAL DRUGS FOR MINOR USE AND MINOR SPECIES

0
3. The authority citation for part 516 continues to read as follows:

    Authority: 360ccc, 360ccc-2, 371.

0
4. Add Sec.  516.2065 to read as follows:

Sec.  516.2065  Rabacfosadine.

    (a) Specifications. Each vial of powder contains 16.4 milligrams 
(mg) rabacfosadine. Each milliliter of constituted solution contains 
8.2 mg rabacfosadine.
    (b) Sponsor. See No. 086072 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use in dogs--(1) Amount. Administer rabacfosadine 
at 1 mg/kilogram body weight as a 30-minute intravenous infusion, once 
every 3 weeks, for up to 5 doses.
    (2) Indications for use. For the treatment of lymphoma in dogs.
    (3) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian. It is a violation of Federal law 
to use this product other than as directed in the labeling.

PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS

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

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

Sec.  520.370  [Amended]

0
6. In Sec.  520.370, in paragraph (c)(2), remove ``(group G, -
hemolytic)'' and in its place add ``(group G, beta-hemolytic)''.

0
7. In Sec.  520.955, revise paragraph (b) to read as follows:

Sec.  520.955  Florfenicol.

* * * * *
    (b) Sponsors. See Nos. 000061, 054925, and 058198 in Sec.  
510.600(c) of this chapter.
* * * * *

0
8. Add Sec.  520.1189 to read as follows:

Sec.  520.1189  Itraconazole.

    (a) Specifications. Each milliliter (mL) of solution contains 10 
milligrams (mg) of itraconazole.
    (b) Sponsor. See No. 058198 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use--(1) Amount. Administer 5 mg/kilogram (kg) 
(0.5 mL/kg) of body weight once daily on alternating weeks for 3 
treatment cycles.
    (2) Indications for use. For the treatment of dermatophytosis 
caused by Microsporum canis in cats.
    (3) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.

Sec.  520.2041  [Amended]

0
9. In Sec.  520.2041, in paragraph (b), remove ``017135, 051311, and 
066916'' and in its place add ``066916, 017135, and 051311''.

0
10. In Sec.  520.2086, revise paragraph (c)(2) to read as follows:

Sec.  520.2086  Sarolaner.

* * * * *
    (c) * * *
    (2) Indications for use. Kills adult fleas, and for the treatment 
and prevention of flea infestations (Ctenocephalides felis), and the 
treatment and control of tick infestations [Amblyomma americanum (lone 
star tick), Amblyomma maculatum (Gulf Coast tick), Dermacentor 
variabilis (American dog tick), Ixodes scapularis (black-legged tick), 
and Rhipicephalus sanguineus (brown dog tick)] for 1 month in dogs 6 
months of age or older and weighing 2.8 pounds or greater.
* * * * *

Sec.  520.2325b  [Amended]

0
11. In Sec.  520.2325b, in paragraph (b), remove ``050749'' and in its 
place add ``016592''.

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

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

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

Sec.  522.313c  [Amended]

0
13. Effective March 13, 2017, in Sec.  522.313c, in paragraph (b), 
remove

[[Page 12170]]

``000409, 054771, and 068330'' and in its place add ``054771 and 
068330''.

0
14. In Sec.  522.2075, revise paragraph (c) to read as follows:

Sec.  522.2075  Robenacoxib.

* * * * *
    (c) Conditions of use--(1) Dogs--(i) Amount. Administer 0.91 mg per 
pound (2 mg/kilogram (kg)) by subcutaneous injection, once daily, for a 
maximum of 3 days. After the initial subcutaneous dose, subsequent 
doses can be given by subcutaneous injection or as the oral tablet in 
dogs weighing at least 5.5 pounds (2.5 kg) and at least 4 months of 
age, for a maximum of 3 total doses over 3 days, not to exceed 1 dose 
per day. See Sec.  520.2075(c)(1) of this chapter.
    (ii) Indications for use. For the control of postoperative pain and 
inflammation associated with soft tissue surgery in dogs at least 4 
months of age for a maximum of 3 days.
    (iii) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.
    (2) Cats--(i) Amount. Administer 0.91 mg per pound (2 mg/kg) by 
subcutaneous injection, once daily, for a maximum of 3 days.
    (ii) Indications for use. For the control of postoperative pain and 
inflammation associated with orthopedic surgery, ovariohysterectomy, 
and castration in cats at least 4 months of age for a maximum of 3 
days.
    (iii) 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
15. The authority citation for part 529 continues to read as follows:

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

Sec.  529.1186  [Amended]

0
16. Effective March 13, 2017, in Sec.  529.1186, in paragraph (b), 
remove ``010019,''.

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

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

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

0
18. In Sec.  558.325, revise paragraph (e)(1)(ii) to read as follows:

Sec.  558.325  Lincomycin.

* * * * *
    (e) * * *
    (1) * * *

----------------------------------------------------------------------------------------------------------------
                                 Combination  in
     Lincomycin  grams/ton          grams/ton        Indications for use        Limitations           Sponsor
----------------------------------------------------------------------------------------------------------------
 
                                                  * * * * * * *
(ii) 2........................  Halofuginone 2.72  Broiler chickens: For   Feed continuously as           016592
                                                    the control of          sole ration.
                                                    necrotic enteritis      Withdraw 4 days
                                                    caused or complicated   before slaughter. Do
                                                    by Clostridium spp.     not feed to laying
                                                    or other organisms      chickens or
                                                    susceptible to          waterfowl.
                                                    lincomycin; and the     Halofuginone
                                                    prevention of           hydrobromide as
                                                    coccidiosis caused by   provided by No.
                                                    Eimeria tenella, E.     016592 in Sec.
                                                    necatrix, E.            510.600 of this
                                                    acervulina, E.          chapter.
                                                    brunetti, E. mivati,
                                                    and E. maxima.
----------------------------------------------------------------------------------------------------------------

* * * * *

    Dated: February 23, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-03930 Filed 2-28-17; 8:45 am]
 BILLING CODE 4164-01-P