Document ID: FDA-2017-N-0002-0019
Agency: fda
Document Type: Rule
Title: New Animal Drugs; Approval of New Animal Drug Applications; Changes of Sponsorship; Change of a Sponsor’s Name and Address
Posted Date: 2018-04-05T04:00Z

[Federal Register Volume 83, Number 66 (Thursday, April 5, 2018)]
[Rules and Regulations]
[Pages 14584-14588]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-06961]

=======================================================================
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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510, 520, 522, 526, and 558

[Docket No. FDA-2017-N-0002]

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

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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

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 October, November, and December 2017. FDA 
is 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 and a change of a sponsor's name and 
address.

DATES: This rule is effective April 5, 2018.

FOR FURTHER INFORMATION CONTACT: George K. Haibel, Center for 
Veterinary Medicine (HFV-6), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 240-402-5689, 
[email protected].

SUPPLEMENTARY INFORMATION: 

[[Page 14585]]

I. Approval Actions

    FDA is amending the animal drug regulations to reflect approval 
actions for NADAs and ANADAs during October, November, and December 
2017, 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 Dockets 
Management Staff (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: https://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: https://www.fda.gov/AnimalVeterinary/Products/ApprovedAnimalDrugProducts/default.htm.

                       Table 1--Original and Supplemental NADAs and ANADAs Approved During
                                      October, November, and December 2017
----------------------------------------------------------------------------------------------------------------
                                                                                Effect of the
 Approval date   File No.       Sponsor        Product name        Species          action      Public documents
----------------------------------------------------------------------------------------------------------------
October 27,       141-467  Elanco US Inc.,   Avilamycin and    Chickens......  Original         FOI Summary; EA/
 2017.                      2500 Innovation   narasin Type C                    approval for     FONSI. \1\
                            Way,              medicated feeds.                  use of
                            Greenfield, IN                                      INTREPITY
                            46140.                                              (avilamycin)
                                                                                and MONTEBAN
                                                                                (narasin) Type
                                                                                A medicated
                                                                                articles to
                                                                                manufacture
                                                                                Type C
                                                                                medicated
                                                                                broiler
                                                                                chicken feeds
                                                                                for the
                                                                                prevention of
                                                                                mortality
                                                                                caused by
                                                                                necrotic
                                                                                enteritis
                                                                                associated
                                                                                with
                                                                                Clostridium
                                                                                perfringens,
                                                                                and the
                                                                                prevention of
                                                                                coccidiosis
                                                                                caused by
                                                                                Eimeria
                                                                                necatrix, E.
                                                                                tenella, E.
                                                                                acervulina, E.
                                                                                brunetti, E.
                                                                                mivati, and E.
                                                                                maxima.
October 27,       141-466  Elanco US Inc.,   Avilamycin,       Chickens......  Original         FOI Summary; EA/
 2017.                      2500 Innovation   narasin, and                      approval for     FONSI. \1\
                            Way,              nicarbazin Type                   use of
                            Greenfield, IN    C medicated                       INTREPITY
                            46140.            feeds.                            (avilamycin)
                                                                                and MAXIBAN
                                                                                (narasin and
                                                                                nicarbazin)
                                                                                Type A
                                                                                medicated
                                                                                articles to
                                                                                manufacture
                                                                                Type C
                                                                                medicated
                                                                                broiler
                                                                                chicken feeds
                                                                                for the
                                                                                prevention of
                                                                                mortality
                                                                                caused by
                                                                                necrotic
                                                                                enteritis
                                                                                associated
                                                                                with
                                                                                Clostridium
                                                                                perfringens,
                                                                                and the
                                                                                prevention of
                                                                                coccidiosis
                                                                                caused by
                                                                                Eimeria
                                                                                necatrix, E.
                                                                                tenella, E.
                                                                                acervulina, E.
                                                                                brunetti, E.
                                                                                mivati, and E.
                                                                                maxima.
November 9,       106-111  Zoetis Inc., 333  TELAZOL           Dogs..........  Supplemental     FOI Summary.
 2017.                      Portage St.,      (tiletamine and                   approval for
                            Kalamazoo, MI     zolazepam for                     intravenous
                            49007.            injection).                       administration
                                                                                in dogs for
                                                                                induction of
                                                                                anesthesia
                                                                                followed by
                                                                                maintenance
                                                                                with an
                                                                                inhalant
                                                                                anesthetic.
November 21,      200-473  Huvepharma EOOD,  TYLOVET (tylosin  Chickens......  Supplemental     FOI Summary.
 2017.                      5th Floor, 3A     tartrate)                         approval for
                            Nikolay Haytov    Soluble Powder.                   the control of
                            Str., 1113                                          mortality
                            Sofia, Bulgaria.                                    caused by
                                                                                necrotic
                                                                                enteritis
                                                                                associated
                                                                                with
                                                                                Clostridium
                                                                                perfringens in
                                                                                broiler
                                                                                chickens.
November 30,      097-505  Zoetis Inc., 333  Lincomycin Type   Swine.........  Supplemental     ................
 2017.                      Portage St.,      B and Type C                      approval for
                            Kalamazoo, MI     medicated feeds.                  use of
                            49007.                                              LINCOMIX
                                                                                (lincomycin)
                                                                                Type A
                                                                                medicated
                                                                                articles to
                                                                                manufacture
                                                                                Type B and
                                                                                Type C
                                                                                medicated
                                                                                swine feeds
                                                                                for reduction
                                                                                in the
                                                                                severity of
                                                                                the effects of
                                                                                respiratory
                                                                                disease
                                                                                associated
                                                                                with
                                                                                Mycoplasma
                                                                                hyopneumoniae.
December 11,      141-441  Virbac AH, Inc.,  IVERHART MAX      Dogs..........  Original         FOI Summary.
 2017.                      3200 Meacham      (ivermectin,                      approval of a
                            Blvd., Ft.        pyrantel                          soft chewable
                            Worth, TX 76137.  pamoate,                          tablet to
                                              praziquantel)                     prevent canine
                                              Soft Chew.                        heartworm
                                                                                disease by
                                                                                eliminating
                                                                                the tissue
                                                                                stage of
                                                                                heartworm
                                                                                larvae
                                                                                (Dirofilaria
                                                                                immitis) for a
                                                                                month (30
                                                                                days) after
                                                                                infection and
                                                                                for the
                                                                                treatment and
                                                                                control of
                                                                                roundworm
                                                                                (Toxocara
                                                                                canis,
                                                                                Toxascaris
                                                                                leonina),
                                                                                hookworm
                                                                                (Ancylostoma
                                                                                caninum,
                                                                                Uncinaria
                                                                                stenocephala,
                                                                                Ancylostoma
                                                                                braziliense),
                                                                                and tapeworm
                                                                                (Dipylidium
                                                                                caninum,
                                                                                Taenia
                                                                                pisiformis)
                                                                                infections.
December 12,      200-617  Pharmgate LLC,    Chlortetracyclin  Cattle........  Original         ................
 2017.                      1800 Sir Tyler    e and lasalocid                   approval for
                            Dr.,              Type B and Type                   use of DERACIN
                            Wilmington, NC    C medicated                       (chlortetracyc
                            28405.            feeds.                            line) and
                                                                                BOVATEC
                                                                                (lasalocid)
                                                                                Type A
                                                                                medicated
                                                                                articles to
                                                                                manufacture
                                                                                Type B and
                                                                                Type C
                                                                                medicated
                                                                                cattle feeds
                                                                                as a generic
                                                                                copy of NADA
                                                                                141-250.
----------------------------------------------------------------------------------------------------------------
\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

    Aratana Therapeutics, Inc., 11400 Tomahawk Creek Pkwy., Leawood, KS 
66211 has informed FDA that it has transferred ownership of, and all 
rights and interest in, the following application to Elanco US, Inc., 
2500 Innovation Way, Greenfield, IN 46140:

[[Page 14586]]

------------------------------------------------------------------------
            File No.                   Product name       21 CFR section
------------------------------------------------------------------------
141-455........................  GALLIPRANT (grapiprant)        520.1084
                                  Tablets.
------------------------------------------------------------------------

    Strategic Veterinary Pharmaceuticals, Inc., 100 NW Airport Rd., St. 
Joseph, MO 64503 has informed FDA that it has transferred ownership of, 
and all rights and interest in, the following applications to HQ 
Specialty Pharma Corp., 120 Rte. 17 North, suite 130, Paramus, NJ 
07652:

------------------------------------------------------------------------
            File No.                   Product name       21 CFR section
------------------------------------------------------------------------
055-097........................  DRY-MAST (pen G               526.1696b
                                  procaine/
                                  dihydrostreptomycin
                                  sulfate) Infusion.
------------------------------------------------------------------------

    Ridley Block Operations Inc., 424 North Riverfront Dr., P.O. Box 
8500, Mankato, MN 56002-8500 has informed FDA that it has transferred 
ownership of, and all rights and interest in, the following 
applications to Ridley USA, Inc., 111 W Cherry St., suite 500, Mankato, 
MN 56001:

------------------------------------------------------------------------
            File No.                   Product name       21 CFR section
------------------------------------------------------------------------
141-187........................  CRYSTALYX IONO-LYX              558.311
                                  (lasalocid) Type C
                                  Medicated Protein
                                  Block.
------------------------------------------------------------------------

    Ridley U.S. Holdings, Inc., 424 North Riverfront Dr., P.O. Box 
8500, Mankato, MN 56002-8500 has informed FDA that it has transferred 
ownership of, and all rights and interest in, the following application 
to Ridley USA, Inc., 111 W Cherry St., suite 500, Mankato, MN 56001:

------------------------------------------------------------------------
            File No.                   Product name       21 CFR section
------------------------------------------------------------------------
033-733........................  SWEETLIX BLOAT-GUARD           520.1840
                                  (poloxalene) Pressed
                                  Block.
------------------------------------------------------------------------

    Accordingly, the animal drug regulations are being amended to 
reflect these changes of sponsorship. Following these withdrawals of 
approval, neither Ridley Block Operations, Inc. nor Ridley U.S. 
Holdings, Inc. is the sponsor of an approved application. Accordingly, 
these firms will be removed from the list of sponsors of approved 
applications in Sec.  510.600(c) (21 CFR 510.600(c)).

III. Legal Authority

    This final rule is issued under section 512(i) of the Federal Food, 
Drug, and Cosmetic Act (FD&C Act) (21 U.S.C.360b(i)), which requires 
Federal Register publication of ``notice[s] . . . effective as a 
regulation,'' of the conditions of use of approved new animal drugs. 
This rule sets forth technical amendments to the regulations to codify 
recent actions on approved new animal drug applications and corrections 
to improve the accuracy of the regulations, and as such does not impose 
any burden on regulated entities.
    Although denominated a rule pursuant to the FD&C Act, this document 
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. 
Likewise, this is not a rule subject to Executive Order 12866, which 
defines a rule as ``an agency statement of general applicability and 
future effect, which the agency intends to have the force and effect of 
law, that is designed to implement, interpret, or prescribe law or 
policy or to describe the procedure or practice requirements of an 
agency.''

List of Subjects

21 CFR Part 510

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

21 CFR Parts 520, 522, and 526

    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, 21 CFR parts 
510, 520, 522, 526, 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), remove the entry 
for ``Ridley Block Operations, Inc.'' and revise the entry for ``Ridley 
U.S. Holdings, Inc.''; and in the table in paragraph (c)(2), remove the 
entry for ``068287'' and revise the entry for ``067949''.
    The revisions read as follows:

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

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

[[Page 14587]]

------------------------------------------------------------------------
             Firm name and address                  Drug labeler code
------------------------------------------------------------------------
 
                              * * * * * * *
Ridley USA, Inc., 111 W Cherry St., Suite 500,                   067949
 Mankato, MN 56001............................
 
                              * * * * * * *
------------------------------------------------------------------------

    (2) * * *

------------------------------------------------------------------------
               Drug labeler code                  Firm name and address
------------------------------------------------------------------------
 
                              * * * * * * *
067949........................................  Ridley USA, Inc., 111 W
                                                                       Cherry St., Suite 500,
                                                     Mankato, MN 56001.
 
                              * * * * * * *
------------------------------------------------------------------------

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.  520.1084   [Amended]

0
4. In Sec.  520.1084, in paragraph (b), remove ``086026'' and in its 
place add ``058198''.

Sec.  520.1199   [Amended]

0
5. In Sec.  520.1199, in paragraph (a) introductory text, remove 
``chewable tablet'' and in its place add ``chewable tablet or soft 
chewable tablet''; and in paragraph (c)(2), remove ``Prevents'' and in 
its place add ``To prevent''.

0
6. In Sec.  520.2640, revise paragraphs (b)(1) and (2) to read as 
follows:

Sec.  520.2640   Tylosin.

* * * * *
    (b) * * *
    (1) Nos. 016592 and 058198 for use as in paragraph (e) of this 
section.
    (2) No. 061623 for use as in paragraphs (e)(1)(i)(A), (e)(1)(ii), 
(e)(2), (e)(3), and (e)(4) of this section.
* * * * *

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

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

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

0
8. In Sec.  522.2470, revise paragraphs (b) and (c) to read as follows:

Sec.  522.2470   Tiletamine and zolazepam for injection.

* * * * *
    (b) Sponsors. See sponsors in Sec.  510.600(c) of this chapter:
    (1) No. 054771 for use as in paragraph (c) of this section.
    (2) Nos. 026637 and 051311 for use as in paragraphs (c)(1)(i)(A), 
(c)(1)(ii)(A), (c)(1)(iii) and (c)(2) of this section.
    (c) Conditions of use--(1) Dogs--(i) Amount. Expressed as 
milligrams of the drug combination:
    (A) An initial intramuscular dosage of 3 to 4.5 milligrams per 
pound (mg/lb) of body weight for diagnostic purposes; 4.5 to 6 mg/lb of 
body weight for minor procedures of short duration such as repair of 
lacerations and wounds, castrations, and other procedures requiring 
mild to moderate analgesia. Supplemental doses when required should be 
less than the initial dose and the total dose given should not exceed 
12 mg/lb of body weight. The maximum total safe dose is 13.6 mg/lb of 
body weight.
    (B) Administer intravenously at 1 to 2 mg/lb (2.2 to 4.4 mg/kg) 
body weight to effect for induction of anesthesia followed by 
maintenance with an inhalant anesthetic.
    (ii) Indications for use. (A) Intramuscular administration in dogs 
for restraint and minor procedures of short duration (30 minutes 
average) requiring mild to moderate analgesia.
    (B) Intravenous administration in dogs for induction of anesthesia 
followed by maintenance with an inhalant anesthetic.
    (iii) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.
    (2) Cats--(i) Amount. An initial intramuscular dosage of 4.4 to 5.4 
mg/lb of body weight is recommended for such procedures as dentistry, 
treatment of abscesses, foreign body removal, and related types of 
surgery; 4.8 to 5.7 mg/lb of body weight for minor procedures requiring 
mild to moderate analgesia, such as repair of lacerations, castrations, 
and other procedures of short duration. Initial dosages of 6.5 to 7.2 
mg/lb of body weight are recommended for ovariohysterectomy and 
onychectomy. When supplemental doses are required, such individual 
supplemental doses should be given in increments that are less than the 
initial dose and the total dose given (initial dose plus supplemental 
doses) should not exceed the maximum allowable safe dose of 32.7 mg/lb 
of body weight.
    (ii) Indications for use. For restraint or for anesthesia combined 
with muscle relaxation.
    (iii) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.

PART 526--INTRAMAMMARY DOSAGE FORM NEW ANIMAL DRUGS

0
9. The authority citation for part 526 continues to read as follows:

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

Sec.  526.1696b   [Amended]

0
10. In Sec.  526.1696b, in paragraph (b), remove ``054628'' and in its 
place add ``042791''.

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

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

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

0
12. In Sec.  558.68, add paragraphs (e)(1)(iii) and (iv) to read as 
follows:

Sec.  558.68  Avilamycin.

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

[[Page 14588]]

----------------------------------------------------------------------------------------------------------------
                                     Combination in
     Avilamycin in grams/ton           grams/ton       Indications for use        Limitations          Sponsor
----------------------------------------------------------------------------------------------------------------
 
                                                  * * * * * * *
(iii) 13.6 to 40.9..............  Narasin,...........  Broiler chickens:    Feed as the sole ration       058198
                                  54 to 90...........   For the prevention   for 21 consecutive
                                                        of mortality         days to chickens that
                                                        caused by necrotic   are at risk of
                                                        enteritis            developing, but not
                                                        associated with      yet showing clinical
                                                        Clostridium          signs of, necrotic
                                                        perfringens; and     enteritis associated
                                                        for the prevention   with Clostridium
                                                        of coccidiosis       perfringens. To assure
                                                        caused by Eimeria    responsible
                                                        necatrix, E.         antimicrobial drug use
                                                        tenella, E.          in broiler chickens,
                                                        acervulina, E.       treatment
                                                        brunetti, E.         administration must
                                                        mivati, and E.       begin on or before 10
                                                        maxima.              days of age. Do not
                                                                             allow adult turkeys,
                                                                             horses, or other
                                                                             equines access to
                                                                             narasin formulations.
                                                                             Ingestion of narasin
                                                                             by these species has
                                                                             been fatal. Narasin as
                                                                             provided by No. 058198
                                                                             in Sec.   510.600(c)
                                                                             of this chapter.
(iv) 13.6 to 40.9...............  Narasin............  Broiler chickens:    Feed as the sole ration       058198
                                  27 to 45;..........   For the prevention   for 21 consecutive
                                  nicarbazin.........   of mortality         days to chickens that
                                  27 to 45...........   caused by necrotic   are at risk of
                                                        enteritis            developing, but not
                                                        associated with      yet showing clinical
                                                        Clostridium          signs of, necrotic
                                                        perfringens; and     enteritis associated
                                                        for the prevention   with Clostridium
                                                        of coccidiosis       perfringens. To assure
                                                        caused by Eimeria    responsible
                                                        necatrix, E.         antimicrobial drug use
                                                        tenella, E.          in broiler chickens,
                                                        acervulina, E.       treatment
                                                        brunetti, E.         administration must
                                                        mivati, and E.       begin on or before 10
                                                        maxima.              days of age. Do not
                                                                             allow adult turkeys,
                                                                             horses, or other
                                                                             equines access to
                                                                             narasin formulations.
                                                                             Ingestion of narasin
                                                                             by these species has
                                                                             been fatal. Do not
                                                                             feed to laying hens.
                                                                             Withdraw 5 days before
                                                                             slaughter. Narasin and
                                                                             nicarbazin as provided
                                                                             by No. 058198 in Sec.
                                                                              510.600(c) of this
                                                                             chapter.
----------------------------------------------------------------------------------------------------------------

* * * * *

Sec.  558.128   [Amended]

0
13. In Sec.  558.128, in paragraph (e)(4), in the ``Sponsor'' column, 
numerically add ``069254'' to paragraphs (e)(4)(ii), (vii), (viii), 
(ix), and (xviii) through (xxvi).

Sec.  558.311   [Amended]

0
14. In Sec.  558.311, in paragraph (b)(9) and in paragraph (e)(1)(xix), 
in the ``Sponsor'' column, remove ``068287'' and in its place add 
``067949''.

0
15. In Sec.  558.325 revise paragraph (e)(2)(xiv) to read as follows:

Sec.  558.325   Lincomycin.

* * * * *
    (e) * * *
    (2) * * *

----------------------------------------------------------------------------------------------------------------
                                   Combination in
      Lincomycin grams/ton            grams/ton        Indications for use        Limitations        Sponsors
----------------------------------------------------------------------------------------------------------------
 
                                                  * * * * * * *
(xiv) 100 to 200...............  ..................  For reduction in the     Feed as sole                054771
                                                      severity of the          ration for 21
                                                      effects of respiratory   days.
                                                      disease associated
                                                      with Mycoplasma
                                                      hyopneumoniae.
 
                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------

* * * * *

    Dated: March 29, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-06961 Filed 4-4-18; 8:45 am]
 BILLING CODE 4164-01-P