81 FR 59131 - New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Changes of Sponsorship; Change of Sponsor's Name and Address; Change of Sponsor's Address

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 167 (August 29, 2016)

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 May and June 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 changes of sponsorship of applications, changes of sponsors' names and addresses, and the voluntary withdrawals of approval of applications.

[Federal Register Volume 81, Number 167 (Monday, August 29, 2016)]
[Rules and Regulations]
[Pages 59131-59135]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-19914]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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

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


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

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 May and June 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 changes of 
sponsorship of applications, changes of sponsors' names and addresses, 
and the voluntary withdrawals of approval of applications.

DATES: This rule is effective August 29, 2016, except for the 
amendments to 21 CFR 558.274, 58.355, 58.363, 58.550, 558.625, and 
558.630, which are effective September 8, 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, 
[email protected].

SUPPLEMENTARY INFORMATION: 

I. Approval Actions

    FDA is amending the animal drug regulations to reflect approval 
actions for NADAs and ANADAs during May and June 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.

[[Page 59132]]



                                  Table 1--Original and Supplemental NADAs and ANADAs Approved During May and June 2016
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                            Indications for use/
       Approval date          File No.         Sponsor              Product name            Species         effect of the action     Public documents
--------------------------------------------------------------------------------------------------------------------------------------------------------
May 2, 2016................    141-439  Elanco Animal Health,  INTEPRITY              Chickens...........  Original approval for  FOI Summary, EA/
                                         A Division of Eli      (avilamycin) Type A                         the prevention of      FONSI.\1\
                                         Lilly & Co., Lilly     medicated article.                          mortality caused by
                                         Corporate Center,                                                  necrotic enteritis
                                         Indianapolis, IN                                                   associated with
                                         46285.                                                             Clostridium
                                                                                                            perfringens in
                                                                                                            broiler chickens.
May 16, 2016...............    141-457  Aratana Therapeutics,  ENTYCE (capromorelin   Dogs...............  Original approval for  FOI Summary.
                                         Inc., 11400 Tomahawk   oral solution).                             appetite stimulation
                                         Creek Pkwy.,                                                       in dogs.
                                         Leawood, KS 66211.
May 17, 2016...............    141-463  Elanco US, Inc., 2500  ONSIOR (robenacoxib)   Dogs...............  Original approval for  FOI Summary.
                                         Innovation Way,        Tablets for Dogs.                           the control of
                                         Greenfield, IN 46140.                                              postoperative pain
                                                                                                            and inflammation
                                                                                                            associated with soft
                                                                                                            tissue surgery in
                                                                                                            dogs.
May 17, 2016...............    200-536  Med-Pharmex, Inc.,     MOMETAVET (gentamicin  Dogs...............  Original approval of   FOI Summary.
                                         2727 Thompson Creek    sulfate, USP;                               a generic copy of
                                         Rd., Pomona, CA        mometasone furoate                          NADA 141-177.
                                         91767-1861.            anhydrous, USP; and
                                                                clotrimazole, USP)
                                                                Otic Suspension.
May 24, 2016...............    200-596  Huvepharma EOOD, 5th   TILMOVET 90            Cattle.............  Original approval for  FOI Summary.
                                         Floor, 3A Nikolay      (tilmicosin                                 use in two-way,
                                         Haytov Str., 1113      phosphate) and                              combination drug
                                         Sophia, Bulgaria.      RUMENSIN 90                                 Type B and Type C
                                                                (monensin) Type A                           medicated feeds for
                                                                medicated articles.                         cattle fed in
                                                                                                            confinement for
                                                                                                            slaughter.
June 20, 2016..............    200-587  Cross Vetpharm Group   FERROFORTE             Piglets............  Original approval as   FOI Summary.
                                         Ltd. Broomhill Rd.,    (gleptoferron                               a generic copy of
                                         Tallaght, Dublin 24,   injection).                                 NADA 110-399.
                                         Ireland.
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ The Agency has carefully considered an environmental assessment (EA) of the potential environmental impact of this action and has made a finding of
  no significant impact (FONSI).

II. Changes of Sponsorship

    Bayer HealthCare LLC, Animal Health Division, P.O. Box 390, 
Shawnee, Mission, KS 66201 has informed FDA that it has transferred 
ownership of, and all rights and interest in, the following approved 
applications to Huvepharma EOOD, 5th Floor, 3A Nikolay Haitov Str., 
1113 Sofia, Bulgaria:

------------------------------------------------------------------------
        File No.                   Product name           21 CFR section
------------------------------------------------------------------------
200-228................  PHOENECTIN (ivermectin)                522.1192
                          Injectable Solution.
200-254................  Iron Dextran Injection, 100 mg/        522.1182
                          mL.
200-256................  Iron Dextran Injection, 200 mg/        522.1182
                          mL.
200-351................  Lincomycin Injectable, USP.....        522.1260
200-389................  Amprolium 9.6% Oral Solution...         520.100
------------------------------------------------------------------------

    As provided in the regulatory text of this document, the animal 
drug regulations are amended to reflect these changes of sponsorship.

III. Withdrawals of Approval

    In addition, during May and June 2016, Elanco US, Inc., 2500 
Innovation Way, Greenfield, IN 46140 requested that FDA withdraw 
approval of the NADAs listed in the following table because the 
products are no longer manufactured or marketed:

------------------------------------------------------------------------
        File No.                   Product name           21 CFR section
------------------------------------------------------------------------
012-548 \1\............  TYLOSIN (tylosin phosphate)/            558.274
                          HYGROMIX (hygromycin B).
013-162 \1\............  TYLAN TM (tylosin phosphate)            558.625
                          Type A medicated article.
013-388 \1\............  TYLAN (tylosin phosphate)/              558.274
                          HYGROMIX (hygromycin B) Premix.
015-166 \1\............  TYLAN TM (tylosin phosphate)            558.625
                          Type A medicated article.
127-507 \1\............  TYLAN 5, 10, 20, or 40 SULFA-G          558.630
                          (tylosin phosphate and
                          sulfamethazine).
141-164 \1\............  TYLAN (tylosin phosphate)/COBAN         558.355
                          (monensin).
141-170 \1\............  TYLAN (tylosin phosphate)/              558.363
                          MONTEBAN (narasin).
141-198 \1\............  TYLAN TM (tylosin phosphate)/           558.550
                          BIO-COX (salinomycin).
------------------------------------------------------------------------
\1\ These NADAs were identified as being affected by guidance for
  industry #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 NADAs 012-548, 013-162, 013-388, 015-166, 127-507, 
141-640, 141-170, and 141-198, and all supplements and amendments 
thereto, is withdrawn, effective September 8, 2016. As provided in the 
regulatory text of this document, the animal drug regulations are 
amended to reflect these voluntary withdrawals of approval.

[[Page 59133]]

IV. Technical Amendments

    FDA has noticed that a drug labeler code in 21 CFR 520.2325a does 
not accurately reflect the sponsorship of a new animal drug 
application. At this time, we are amending this section. This action is 
being taken to improve the accuracy of the regulations.
    Also, ConAgra Pet Products Co., 3902 Leavenworth St., Omaha, NE 
68105 has informed FDA that it is changing its name and address to 
Sergeant's Pet Care Products, Inc., 10077 S. 134th St., Omaha, NE 
68138.
    Alexion Pharmaceuticals, Inc., 33 Hayden Ave., Lexington, MA 02421 
has informed FDA that it has changed its address to 100 College St., 
New Haven, CT 06510. At this time, this firm is being added to the list 
of sponsors of approved application in 21 CFR 510.600(c) which we had 
not done previously.
    FDA has noticed that the maximum concentration of sulfadimethoxine 
with ormetoprim in 2-way, fixed-ratio combination drug Type B medicated 
feeds in 21 CFR 558.4 was amended in error. At this time, we are 
revising this section to provide for appropriate concentrations in Type 
B medicated feeds for salmonids and catfish. This action is being taken 
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, and 524

    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, 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. In Sec.  510.600, in the table in paragraph (c)(1), alphabetically 
add an entry for ``Alexion Pharmaceuticals, Inc.'', remove the entry 
for ``ConAgra Pet Products Co.'', and alphabetically add an entry for 
``Sergeant's Pet Care Products, Inc.''; and in the table in paragraph 
(c)(2), revise the entry for ``021091'' and numerically add an entry 
for ``069334''.
    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
------------------------------------------------------------------------
 
                              * * * * * * *
Alexion Pharmaceuticals, Inc., 100 College St., New               069334
 Haven, CT 06510........................................
 
                              * * * * * * *
Sergeant's Pet Care Products, Inc., 10077 S. 134th St.,           021091
 Omaha, NE 68138........................................
 
                              * * * * * * *
------------------------------------------------------------------------

    (2) * * *

------------------------------------------------------------------------
        Drug labeler code                  Firm name and address
------------------------------------------------------------------------
 
                              * * * * * * *
021091..........................  Sergeant's Pet Care Products, Inc.,
                                   10077 S. 134th St., Omaha, NE 68138.
 
                              * * * * * * *
069334..........................  Alexion Pharmaceuticals, Inc., 100
                                   College St., New Haven, CT 06510.
 
                              * * * * * * *
------------------------------------------------------------------------

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.


Sec.  520.100   [Amended]

0
4. In Sec.  520.100, remove paragraphs (b)(3) and (4).


Sec. Sec.  520.300, 520.300a, 520.300b, and 520.300c  [Redesignated as 
Sec. Sec.  520.284, 520.284a, 520.284b, and 520.284c.]

0
5. Redesignate Sec. Sec.  520.300, 520.300a, 520.300b, and 520.300c as 
Sec. Sec.  520.284, 520.284a, 520.284b, and 520.284c.

0
6. Add Sec.  520.292 to read as follows:


Sec.  520.292  Capromorelin.

    (a) Specifications. Each milliliter of solution contains 30 
milligrams (mg) capromorelin.
    (b) Sponsor. See No. 086026 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use in dogs--(1) Amount. Administer 3 mg/kg once 
daily by mouth.
    (2) Indications for use. For appetite stimulation in dogs.
    (3) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.

0
7. In Sec.  520.2075, revise paragraphs (a) and (c) to read as follows:

[[Page 59134]]

Sec.  520.2075  Robenacoxib.

    (a) Specifications. Each tablet contains 10, 20, or 40 milligrams 
(mg) robenacoxib for use in dogs, or 6 mg robenacoxib for use in cats.
* * * * *
    (c) Conditions of use--(1) Dogs--(i) Amount. Administer 0.91 mg/lb 
(2 mg/kg) orally, once daily, for a maximum of 3 days.
    (ii) Indications for use. For the control of postoperative pain and 
inflammation associated with soft tissue surgery in dogs weighing at 
least 5.5 lb (2.5 kg) and 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 0.45 mg/lb (1 mg/kg) orally, 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 weighing at least 5.5 lb (2.5 kg) and 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.


Sec.  520.2325a  [Amended]

0
8. In Sec.  520.2325a, in paragraph (a)(3), remove ``053501'' and in 
its place add ``054771''.

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

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

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


0
10. Revise Sec.  522.1055 to read as follows:


Sec.  522.1055  Gleptoferron.

    (a) Specifications. Each milliliter (mL) contains the equivalent of 
200 milligrams of elemental iron as gleptoferron, a complex of ferric 
hydroxide and dextran glucoheptonic acid.
    (b) Sponsors. See Nos. 059120 and 061623 in Sec.  510.600(c) of 
this chapter.
    (c) Conditions of use in swine--(1) Indications for use and 
amounts--(i) Prevention of anemia due to iron deficiency: Administer 1 
mL (200 mg iron) per pig by intramuscular injection on or before 3 days 
of age.
    (ii) Treatment of anemia due to iron deficiency: Administer 1 mL 
(200 mg iron) per pig by intramuscular injection as soon as signs of 
deficiency appear.
    (2) [Reserved]


Sec.  522.1182  [Amended]

0
11. In Sec.  522.1182, in paragraph (b) introductory text, remove 
``baby pigs'' and in its place add ``young piglets''; in paragraph 
(b)(7) introductory text, remove ``000859'' and in its place add 
``016592''; and in paragraphs (b)(7)(i) and (ii), remove ``baby pig''.


Sec.  522.1192  [Amended]

0
12. In Sec.  522.1192, in paragraph (b)(2), remove ``000859'' and in 
its place add ``016592,''.


Sec.  522.1260  [Amended]

0
13. In Sec.  522.1260, in paragraph (b)(2), remove ``000859'' and in 
its place add ``016592''.

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

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

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

0
15. In Sec.  524.1044h, revise paragraphs (a) and (b) to read as 
follows:


Sec.  524.1044h  Gentamicin, mometasone, and clotrimazole otic 
suspension.

    (a) Specifications. Each gram of suspension contains gentamicin 
sulfate, United States Pharmacopeia (USP) equivalent to 3 milligram 
(mg) gentamicin base, mometasone furoate monohydrate or mometasone 
furoate anhydrous, USP, equivalent to 1 mg mometasone, and 10 mg 
clotrimazole, USP.
    (b) Sponsors. See Nos. 000061 and 054925 in Sec.  510.600(c) of 
this chapter.
* * * * *

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

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

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


Sec.  558.4  [Amended]

0
17. In Sec.  558.4, in paragraph (d), in the ``Category I'' table, in 
the ``Type B maximum (200 x)'' column, in the row entry for 
``Avilamycin'', remove ``3.65 g/lb (0.8%)'' and in its place add ``7.3 
g/lb (1.6%)''; and in the ``Category II'' table, remove the row entry 
for ``Sulfadimethoxine'' and two following row entries for 
``Ormetoprim'', and in their place add row entries for 
``Sulfadimethoxine'' and ``Ormetoprim''.
    The additions read as follows:


Sec.  558.4  Requirement of a medicated feed mill license.

* * * * *
    (d) * * *

                                                   Category II
----------------------------------------------------------------------------------------------------------------
                                                Assay limits
                    Drug                      percent \1\ Type      Type B maximum (100 x)        Assay limits
                                                     A                                          percent Type B/C
----------------------------------------------------------------------------------------------------------------
 
                                                  * * * * * * *
Sulfadimethoxine...........................             90-110  Poultry: 5.675 g/lb..........      80-115/75-125
                                                                Fish: 85.1 g/lb..............
Ormetoprim.................................             90-110  Poultry: 3.405 g/lb..........             80-115
                                                                Fish: 17.0 g/lb..............
 
                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------

* * * * *

0
18. In Sec.  558.68, revise paragraphs (a) and (e) to read as follows:


Sec.  558.68  Avilamycin.

    (a) Each pound of Type A medicated article contains 45.4 or 90.7 
grams of avilamycin.
* * * * *
    (e) Conditions of use. Administer in feed as follows:
    (1) Chickens--

[[Page 59135]]



----------------------------------------------------------------------------------------------------------------
                                    Combination in
      Avilamycin in grams/ton          grams/ton     Indications for use        Limitations           Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 13.6 to 40.9..................  ..............  Broiler chickens: For  Feed as the sole               000986
                                                     the prevention of      ration for 21
                                                     mortality caused by    consecutive days. To
                                                     necrotic enteritis     assure responsible
                                                     associated with        antimicrobial drug
                                                     Clostridium            use in broiler
                                                     perfringens in         chickens, treatment
                                                     broiler chickens.      administration must
                                                                            begin on or before
                                                                            10 days of age.
(ii) [Reserved]...................
----------------------------------------------------------------------------------------------------------------

    (2) Swine--

----------------------------------------------------------------------------------------------------------------
                                     Combinationin
      Avilamycin in grams/ton          grams/ton     Indications for use        Limitations           Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 73............................  ..............  Weaned pigs less than  Feed as the sole               000986
                                                     14 weeks of age: For   ration for 21
                                                     the reduction in       consecutive days. To
                                                     incidence and          assure responsible
                                                     overall severity of    antimicrobial drug
                                                     diarrhea in the        use in pigs, do not
                                                     presence of            administer to pigs
                                                     pathogenic             14 weeks of age or
                                                     Escherichia coli in    older.
                                                     groups of weaned
                                                     pigs.
(ii) [Reserved]...................
----------------------------------------------------------------------------------------------------------------

Sec.  558.274  [Amended]

0
19. Effective September 8, 2016, in Sec.  558.274, remove and reserve 
paragraphs (c)(1)(ii) and (c)(2)(ii).

0
20. Effective September 8, 2016, in Sec.  558.355, remove and reserve 
paragraph (f)(1)(xxviii) and revise paragraphs (f)(8)(i) and (ii).
    The revisions read as follows:


Sec.  558.355  Monensin.

* * * * *
    (f) * * *
    (8) * * *
    (i) Decoquinate alone and in combination as in Sec.  558.195.
    (ii) Melengestrol acetate alone and in combination as in Sec.  
558.342.
* * * * *


Sec.  558.363  [Amended]

0
21. Effective September 8, 2016, in Sec.  558.363, remove and reserve 
paragraph (d)(1)(vi).


Sec.  558.550  [Amended]

0
22. Effective September 8, 2016, in Sec.  558.550, remove and reserve 
paragraph (d)(1)(xxii).


Sec.  558.618  [Amended]

0
23. In Sec.  558.618, in paragraphs (e)(2)(ii) and (iii):
0
a. In the ``Limitations'' column, add ``Tilmicosin as provided by Nos. 
000986 or 016952; monensin as provided by No. 000986 in Sec.  
510.600(c) of this chapter.'' to the end of the existing entries; and
0
b. In the ``Sponsor'' column, numerically add ``016952''.

0
24. Effective September 8, 2016, in Sec.  558.625, revise paragraphs 
(b)(1), (f)(2)(i), (f)(2)(iii), and (f)(2)(vii) and remove paragraphs 
(f)(2)(viii) and (ix).
    The revisions read as follows:


Sec.  558.625  Tylosin.

* * * * *
    (b) * * *
    (1) No. 000986: 40 and 100 grams per pound for use as in paragraph 
(f) of this section.
* * * * *
    (f) * * *
    (2) * * *
    (i) Decoquinate alone and in combination as in Sec.  558.195.
* * * * *
    (iii) Melengestrol acetate alone and in combination as in Sec.  
558.342.
* * * * *
    (vii) Zilpaterol alone and in combination as in Sec.  558.665.

0
25. Effective September 8, 2016, in Sec.  558.630, revise paragraph 
(b)(1) to read as follows:


Sec.  558.630  Tylosin and sulfamethazine.

* * * * *
    (b) * * *
    (1) No. 000986: 40 and 100 grams per pound for use as in paragraph 
(e) of this section.
* * * * *

    Dated: August 8, 2016.
Tracey H. Forfa,
Deputy Director, Center for Veterinary Medicine.
[FR Doc. 2016-19914 Filed 8-26-16; 8:45 am]
 BILLING CODE 4164-01-P