Document ID: FDA-2012-N-0002-0031
Agency: fda
Document Type: Rule
Title: New Animal Drugs; Approvals; Changes of Sponsor; Change of Sponsor's Name; Change of Sponsor's Address: Alfaxalone; Ivermectin and Clorsulon; Narasin; Triptorelin
Posted Date: 2012-10-23T04:00Z

[Federal Register Volume 77, Number 205 (Tuesday, October 23, 2012)]
[Rules and Regulations]
[Pages 64715-64718]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-25989]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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

[Docket No. FDA-2012-N-0002]

New Animal Drugs; Approvals; Changes of Sponsor; Change of 
Sponsor's Name; Change of Sponsor's Address; Alfaxalone; Ivermectin and 
Clorsulon; Narasin; Triptorelin

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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

SUMMARY: The Food and Drug Administration (FDA) is amending the animal 
drug regulations to reflect approval actions for new animal drug 
applications (NADAs) and abbreviated new animal drug applications 
(ANADAs) during September 2012. FDA is also informing the public of the 
availability of summaries the basis of approval and of environmental 
review documents, where applicable. The animal drug regulations are 
also being amended to reflect a change of sponsorship for four 
ophthalmic ointments, a change of sponsor's name, and a change of 
sponsor's address.

DATES: This rule is effective October 23, 2012.

FOR FURTHER INFORMATION CONTACT: George K. Haibel, Center for 
Veterinary Medicine (HFV-6), Food and Drug Administration, 7519 
Standish Pl., Rockville, MD 20855, 240-276-9019, email: 
george.haibel@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: FDA is amending the animal drug regulations 
to reflect approval actions during September 2012, as listed in table 
1. With respect to these actions, FDA is also 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 through the Center for Veterinary Medicine's 
FOIA Electronic Reading Room. FOI Summaries may be found listed by 
application number at: http://www.fda.gov/AnimalVeterinary/Products/ApprovedAnimalDrugProducts/FOIADrugSummaries/default.htm. Environmental 
Assessments (EAs) and Finding Of No Serious Impacts (FONSIs) may be 
found listed by the established name of the active pharmaceutical 
ingredient at: http://www.fda.gov/AnimalVeterinary/DevelopmentApprovalProcess/EnvironmentalAssessments/ucm300656.htm.
    Also, Fougera Pharmaceuticals, Inc., P.O. Box 2006, 60 Baylis Rd., 
Melville, NY 11747, has informed FDA that it has transferred ownership 
of, and all rights and interest in, NADA 065-015 for VETROPOLYCIN HC 
(bacitracin zinc, polymyxin B sulfate, neomycin sulfate, and 
hydrocortisone) Ophthalmic Ointment, NADA 065-016 for VETROPOLYCIN 
(bacitracin zinc, neomycin sulfate, and polymyxin B sulfate) Ophthalmic 
Ointment, NADA 065-460 for VETROCLORICIN (chloramphenicol) Ophthalmic 
Ointment, and ANADA 200-273 for VETRO-GEN (gentamicin sulfate) 
Ophthalmic Ointment to Dechra Ltd., Dechra House, Jamage Industrial 
Estate, Talke Pits, Stoke-on-Trent, Staffordshire, ST7 1XW, United 
Kingdom. Accordingly, the Agency is amending the regulations in 21 CFR 
part 524 to reflect these changes.
    In addition, UDL Laboratories, Inc., 12720 Dairy Ashford Rd., Sugar 
Land, TX 77478, has informed FDA that it has changed its name to Mylan 
Institutional, Inc., and ECO LLC, 8209 Hollister Ave., Las Vegas, NV 
89131 has informed FDA of a change of address to 344 Nassau St., 
Princeton, NJ 08540. Accordingly, the Agency is amending the 
regulations in 21 CFR 510.600(c) to reflect these changes.

                                      Table 1--Original and Supplemental NADAs and ANADAs Approved During July 2012
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                             New animal drug                               21 CFR
          NADA/  ANADA                   Sponsor              product name               Action           Section     FOIA  Summary       NEPA  Review
--------------------------------------------------------------------------------------------------------------------------------------------------------
141-339........................  JBS United Animal       OVUGEL (triptorelin     Original approval for    529.2620  yes..............  CE \1\
                                  Health II LLC, 322 S.   acetate).               the synchronization
                                  Main St., Sheridan,                             of time of
                                  IN 46069.                                       insemination in
                                                                                  weaned sows to
                                                                                  facilitate a single
                                                                                  fixed-time artificial
                                                                                  insemination.
141-340........................  Elanco Animal Health,   SKYCIS 100 (narasin)    Original approval for     558.363  yes..............  EA/
                                  A Division of Eli       Type A medicated        use in medicated feed                                FONSI \2\
                                  Lilly & Co., Lilly      article.                for increased rate of
                                  Corporate Center,                               weight gain and
                                  Indianapolis, IN                                improved feed
                                  46285.                                          efficiency in growing-
                                                                                  finishing swine.
141-342........................  Jurox Pty. Ltd., 85     ALFAXAN (alfaxalone)    Original approval for      522.52  yes..............  CE \1\
                                  Gardiner Rd.,           Intravenous             the induction and
                                  Rutherford, NSW 2320,   Injectable Anesthetic   maintenance of
                                  Australia.              for Cats and Dogs.      anesthesia and for
                                                                                  induction of
                                                                                  anesthesia followed
                                                                                  by maintenance with
                                                                                  an inhalant
                                                                                  anesthetic, in dogs
                                                                                  and cats.

[[Page 64716]]

 
200-466........................  Sparhawk Laboratories,  SPARMECTIN Plus         Original approval as a   522.1193  yes..............  CE \1\
                                  Inc., 12340 Santa Fe    Clorsulon (ivermectin   generic copy of NADA
                                  Trail Dr., Ft.          and clorsulon)          140-833.
                                  Lenexa, KS 66215.       Injection for Cattle.
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ The Agency has determined under 21 CFR 25.33 that this action is categorically excluded (CE) from the requirement to submit an EA or an
  environmental impact statement (EIS) because it is of a type that does not individually or cumulatively have a significant effect on the human
  environment.
\2\ Based on its review of an EA submitted by the sponsor, the Agency has concluded that this action will not have a significant impact on the human
  environment and that an EIS is not required. A FONSI has been prepared.

    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 522, 524, and 529

    Animal drugs.

21 CFR Part 558

    Animal drugs, Animal feeds.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs and 
redelegated to the Center for Veterinary Medicine, 21 CFR parts 510, 
522, 524, 529, and 558 are amended as follows:

PART 510--NEW ANIMAL DRUGS

0
1. The authority citation for 21 CFR part 510 continues to read as 
follows:

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

0
2. Amend Sec.  510.600 as follows:
0
a. In the table in paragraph (c)(1), revise the entry for ``ECO LLC''; 
alphabetically add entries for ``Jurox Pty. Ltd.'', ``JBS United Animal 
Health II LLC'', and ``Mylan Institutional, Inc.''; and remove the 
entry for ``UDL Laboratories, Inc.''; and
0
b. In the table in paragraph (c)(2), numerically add entries for 
``049480'' and ``051233'' and revise the entries for ``051079'' and 
``066916''.
    The additions and revisions read as follows:

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

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

------------------------------------------------------------------------
                                                                  Drug
                    Firm name and address                       labeler
                                                                  code
------------------------------------------------------------------------
 
                              * * * * * * *
ECO LLC, 344 Nassau St., Princeton, NJ 08540.................     066916
 
                              * * * * * * *
JBS United Animal Health II LLC, 322 S. Main St., Sheridan,       051233
 IN 46069....................................................
 
                              * * * * * * *
Jurox Pty. Ltd., 85 Gardiner Rd., Rutherford, NSW 2320,           049480
 Australia...................................................
 
                              * * * * * * *
Mylan Institutional, Inc., 12720 Dairy Ashford Rd., Sugar         051079
 Land, TX 77478..............................................
 
                              * * * * * * *
------------------------------------------------------------------------

     (2) * * *

------------------------------------------------------------------------
         Drug labeler code                  Firm name and address
------------------------------------------------------------------------
 
                              * * * * * * *
049480............................  Jurox Pty. Ltd., 85 Gardiner Rd.,
                                     Rutherford, NSW 2320, Australia.
 
                              * * * * * * *
051079............................  Mylan Institutional, Inc., 12720
                                     Dairy Ashford Rd., Sugar Land, TX
                                     77478.
 
                              * * * * * * *
051233............................  JBS United Animal Health II LLC, 322
                                     S. Main St., Sheridan, IN 46069.
 
                              * * * * * * *
066916............................  ECO LLC, 344 Nassau St., Princeton,
                                     NJ 08540.
 
                              * * * * * * *
------------------------------------------------------------------------

[[Page 64717]]

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

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

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

0
4. Add Sec.  522.52 to read as follows:

Sec.  522.52  Alfaxalone.

    (a) Specifications. Each milliliter contains 10 milligrams (mg) 
alfaxalone.
    (b) Sponsor. See No. 049480 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use in cats and dogs--(1) Amount--(i) Cats--(A) 
Induction of general anesthesia. Administer by intravenous injection 
over approximately 60 seconds or until clinical signs show the onset of 
anesthesia, 2.2 to 9.7 mg/kilogram (kg) for cats that did not receive a 
preanesthetic or 1.0 to 10.8 mg/kg for cats that received a 
preanesthetic.
    (B) Maintenance of general anesthesia following induction. 
Administer an intravenous bolus containing 1.1 to 1.3 mg/kg to provide 
an additional 7 to 8 minutes of anesthesia in preanesthetized cats; a 
dose containing 1.4 to 1.5 mg/kg provides an additional 3 to 5 minutes 
anesthesia in unpreanesthetized cats.
    (ii) Dogs--(A) Induction of general anesthesia. Administer by 
intravenous injection over approximately 60 seconds or until clinical 
signs show the onset of anesthesia, 1.5 to 4.5 mg/kg for dogs that did 
not receive a preanesthetic or 0.2 to 3.5 mg/kg for dogs that received 
a preanesthetic.
    (B) Maintenance of general anesthesia following induction. 
Administer an intravenous bolus containing 1.2 to 1.4 mg/kg to provide 
an additional 6 to 8 minutes of anesthesia in preanesthetized dogs; a 
dose of 1.5 to 2.2 mg/kg provides an additional 6 to 8 minutes of 
anesthesia in unpreanesthetized dogs.
    (2) Indications for use. For the induction and maintenance of 
anesthesia and for induction of anesthesia followed by maintenance with 
an inhalant anesthetic, in dogs and cats.
    (3) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.

0
5. In Sec.  522.1193, revise paragraph (b) to read as follows:

Sec.  522.1193  Ivermectin and clorsulon.

* * * * *
    (b) Sponsors. See Nos. 050604, 055529, and 058005 in Sec.  
510.600(c) of this chapter.
* * * * *

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

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

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

Sec.  524.154  [Amended]

0
7. In Sec.  524.154, in paragraph (a)(2), remove ``025463'' and in its 
place add ``043264''; and in paragraph (b)(3), remove the first 
sentence.

Sec.  524.155  [Amended]

0
8. In Sec.  524.155, in paragraph (a)(2), remove ``025463'' and in its 
place add ``043264''; and in paragraph (b)(3), remove the first and 
second sentences.

Sec.  524.390  [Amended]

0
9. In Sec.  524.390, in paragraph (b), remove ``025463'' and in its 
place add ``043264''.

Sec.  524.1044c  [Amended]

0
10. In Sec.  524.1044c, in paragraph (b), remove ``025463'' and in its 
place add ``043264''.

PART 529--CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS

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

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

0
12. Add Sec.  529.2620 to read as follows:

Sec.  529.2620  Triptorelin.

    (a) Specifications. Each milliliter of gel contains 100 micrograms 
(mcg) triptorelin as triptorelin acetate.
    (b) Sponsor. See No. 051233 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use in swine--(1) Amount. Administer 200 mcg 
intravaginally approximately 96 hours after weaning.
    (2) Indications for use. For the synchronization of time of 
insemination in weaned sows to facilitate a single fixed-time 
artificial insemination.
    (3) Limitations. Not approved for use in gilts. Safety and 
effectiveness have not been evaluated in these animals. Should not be 
used in sows with obvious reproductive tract abnormalities.

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

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

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

0
14. In Sec.  558.363, add paragraphs (a)(8) and (c); revise paragraph 
(d)(1)(xi)(B); redesignate paragraph (d)(2) as paragraph (d)(3); and 
add new paragraph (d)(2) to read as follows:

Sec.  558.363  Narasin.

    (a) * * *
    (8) To 000986: 45.4 grams per pound for use as in paragraph (d)(2) 
of this section.
* * * * *
    (c) Special considerations. An expiration date of 2 months (8 
weeks) is required for narasin Type C medicated swine feeds.
    (d) * * *
    (1) * * *
    (xi) * * *
    (B) Limitations. For broiler chickens only. Feed continuously as 
sole ration. Do not allow adult turkeys, horses, or other equines 
access to formulations containing narasin. Ingestion of narasin by 
these species has been fatal. Narasin and tylosin as provided by 000986 
in Sec.  510.600(c) of this chapter.
    (2) Growing-finishing swine--(i) Amount per ton. Narasin, 13.6 to 
27.2 grams.
    (A) Indications for use. For increased rate of weight gain when fed 
for at least 4 weeks.
    (B) Limitations. Feed continuously for at least 4 weeks to swine 
during the growing-finishing period as the sole ration. No increased 
benefit in rate of weight gain has been shown when narasin 
concentrations in the diet are greater than 13.6 g/ton. Effectiveness 
has not been demonstrated when fed for durations less than 4 weeks. Do 
not allow adult turkeys, horses, or other equines access to narasin 
formulations. Ingestion of narasin by these species has been fatal. Not 
approved for use in breeding animals because safety and effectiveness 
have not been evaluated in these animals. Swine being fed with narasin 
should not have access to feeds containing pleuromutilins (e.g., 
tiamulin) as adverse reactions may occur. If signs of toxicity occur, 
discontinue use.
    (ii) Amount per ton. Narasin, 18.1 to 27.2 grams.
    (A) Indications for use. For increased rate of weight gain and 
improved feed efficiency when fed for at least 4 weeks.
    (B) Limitations. Feed continuously for at least 4 weeks to swine 
during the growing-finishing period as the sole ration. No increased 
benefit in rate of weight gain has been shown when narasin 
concentrations in the diet are greater than 13.6 g/ton. Effectiveness 
has not been demonstrated when fed for durations less than 4 weeks. Do 
not allow adult turkeys, horses, or other equines access to narasin 
formulations. Ingestion of narasin by these species has been fatal. Not 
approved for use in

[[Page 64718]]

breeding animals because safety and effectiveness have not been 
evaluated in these animals. Swine being fed with narasin should not 
have access to feeds containing pleuromutilins (e.g., tiamulin) as 
adverse reactions may occur. If signs of toxicity occur, discontinue 
use.
* * * * *

    Dated: October 17, 2012.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2012-25989 Filed 10-22-12; 8:45 am]
BILLING CODE 4160-01-P