Document ID: FDA-2012-N-0002-0032
Agency: fda
Document Type: Rule
Title: New Animal Drugs: Enrofloxacin; Melengestrol; Meloxicam; Pradofloxacin; Tylosin
Posted Date: 2012-12-31T05:00Z

[Federal Register Volume 77, Number 250 (Monday, December 31, 2012)]
[Rules and Regulations]
[Pages 76862-76864]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-31397]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 520, 522, 529, and 558

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

New Animal Drugs; Enrofloxacin; Melengestrol; Meloxicam; 
Pradofloxacin; Tylosin

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 November 2012. FDA is also informing the public of the 
availability of summaries the basis of approval and of environmental 
review documents, where applicable.

DATES: This rule is effective December 31, 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 original and supplemental approval actions during November 
2012, as listed in table 1 of this document. 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

[[Page 76863]]

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 Center for Veterinary Medicine FOIA Electronic Reading 
Room: http://www.fda.gov/AboutFDA/CentersOffices/OfficeofFoods/CVM/CVMFOIAElectronicReadingRoom/default.htm.
    This rule does not meet the definition of ``rule'' in 5 U.S.C. 
804(3)(A) because it is a rule of ``particular applicability.'' 
Therefore, it is not subject to the congressional review requirements 
in 5 U.S.C. 801-808.

                                    Table 1--Original and Supplemental NADAs and ANADAs Approved During November 2012
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                       New animal drug                                                              FOIA
          NADA/ ANADA                  Sponsor          product name              Action                 21 CFR Section           summary    NEPA review
--------------------------------------------------------------------------------------------------------------------------------------------------------
141-344........................  Bayer HealthCare    VERAFLOX            Original approval for                        520.1860          Yes  CE \1\
                                  LLC, Animal         (pradofloxacin)     the treatment of skin
                                  Health Division,    Oral Suspension     infections (wounds and
                                  P.O. Box 390,       for Cats.           abscesses) in cats
                                  Shawnee Mission,                        caused by susceptible
                                  KS 66201.                               strains of Pasteurella
                                                                          multocida,
                                                                          Streptococcus canis,
                                                                          S. aureus, S. felis,
                                                                          and S.
                                                                          pseudintermedius.
141-346........................  Abbott              OROCAM (meloxicam)  Original approval for                        529.1350          Yes  CE \1\
                                  Laboratories,       Transmucosal Oral   the control of pain
                                  Inc., North         Spray.              and inflammation
                                  Chicago, IL 60064.                      associated with
                                                                          osteoarthritis in dogs.
141-068........................  Bayer HealthCare    BAYTRIL 100         Supplemental approval                         522.812          Yes  CE \1\
                                  LLC, Animal         (enrofloxacin)      adding treatment and
                                  Health Division,    Injectable          control of swine
                                  P.O. Box 390,       Solution.           respiratory disease
                                  Shawnee Mission,                        associated with
                                  KS 66201.                               Bordetella
                                                                          bronchiseptica and
                                                                          Mycoplasma
                                                                          hyopneumoniae.
200-534........................  Huvepharma AD, 5th  TYLOVET 100         Original approval as a                        558.342          Yes  CE \1\
                                  Floor, 3A Nikolay   (tylosin            generic copy of NADA
                                  Haitov St., 1113    phosphate) and      138-870.
                                  Sophia, Bulgaria.   RUMENSIN
                                                      (monensin) and
                                                      MGA
                                                      (melengestrone
                                                      acetate) liquid
                                                      and dry,
                                                      combination drug
                                                      Type C medicated
                                                      feeds.
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ The Agency has determined under 21 CFR 25.33 that this action is categorically excluded (CE) from the requirement to submit an environmental
  assessment or an environmental impact statement because it is of a type that does not individually or cumulatively have a significant effect on the
  human environment.

List of Subjects

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 520, 
522, 529, and 558 are amended as follows:

PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS

0
1. The authority citation for 21 CFR part 520 continues to read as 
follows:

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

0
2. Add Sec.  520.1860 to read as follows:

Sec.  520.1860  Pradofloxacin.

    (a) Specifications. Each milliliter of suspension contains 25 
milligrams (mg) pradofloxacin.
    (b) Sponsor. See No. 000859 in Sec.  510.600(c) of this chapter.
    (c) Special considerations. Federal law restricts this drug to use 
by or on the order of a licensed veterinarian. Federal law prohibits 
the extralabel use of this drug in food-producing animals.
    (d) Conditions of use in cats--(1) Amount. Administer 3.4 mg/lb 
(7.5 mg/kg) body weight once daily for 7 consecutive days.
    (2) Indications for use. For the treatment of skin infections 
(wounds and abscesses) in cats caused by susceptible strains of 
Pasteurella multocida, Streptococcus canis, Staphylococcus aureus, 
Staphylococcus felis, and Staphylococcus pseudintermedius.

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. In Sec.  522.812, revise paragraph (e)(3)(ii) to read as follows:

Sec.  522.812  Enrofloxacin.

* * * * *
    (e) * * *
    (3) * * *
    (ii) Indications for use. For the treatment and control of swine 
respiratory disease (SRD) associated with Actinobacillus 
pleuropneumoniae, Pasteurella multocida, Haemophilus parasuis, 
Streptococcus suis, Bordetella bronchiseptica, and Mycoplasma 
hyopneumoniae.
* * * * *

PART 529--CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS

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

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

0
6. Add Sec.  529.1350 to read as follows:

Sec.  529.1350  Meloxicam.

    (a) Specifications. Each milliliter of solution contains 5 
milligrams (mg) meloxicam.
    (b) Sponsor. See No. 000074 in Sec.  510.600(c) of this chapter.

[[Page 76864]]

    (c) Conditions of use in dogs--(1) Amount. Administer 0.1 mg per 
kilogram of body weight once daily using the metered dose pump.
    (2) Indications for use. For the control of pain and inflammation 
associated with osteoarthritis in dogs.
    (3) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.

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

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

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

Sec.  558.342  [Amended]

0
8. In Sec.  558.342, in the table, in paragraph (e)(1)(xi), in the 
``Limitations'' column, revise the last sentence to read ``Monensin 
provided by No. 000986 and tylosin provided by Nos. 000986 and 016592 
in Sec.  510.600(c) of this chapter.''; and in the ``Sponsor'' column, 
add ``016592''.

    Dated: December 26, 2012.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2012-31397 Filed 12-28-12; 8:45 am]
BILLING CODE 4160-01-P