Document ID: FDA-2012-N-0002-0020
Agency: fda
Document Type: Rule
Title: New Animal Drugs: Cephalexin; Fentanyl; Milbemycin Oxime and Praziquantel
Posted Date: 2012-08-09T04:00Z

[Federal Register Volume 77, Number 154 (Thursday, August 9, 2012)]
[Rules and Regulations]
[Pages 47511-47512]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-19498]

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  Federal Register / Vol. 77, No. 154 / Thursday, August 9, 2012 / 
Rules and Regulations  

[[Page 47511]]

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510, 520, and 524

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

New Animal Drugs; Cephalexin; Fentanyl; Milbemycin Oxime and 
Praziquantel

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 June 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 August 9, 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's Center for Veterinary Medicine is 
adopting use of a monthly Federal Register document to codify approval 
actions for new animal drug applications (NADAs) and abbreviated new 
animal drug application (ANADAs). CVM will no longer publish a separate 
rule for each action. This approach will allow a more efficient use of 
available resources.
    In this document, FDA is amending the animal drug regulations to 
reflect the original and supplemental approval actions during June 
2012, 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.

                                      Table 1--Original and Supplemental NADAs and ANADAs Approved During June 2012
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                               New animal drug
     NADA/ANADA             Sponsor              product name                Action            21 CFR  section     FOIA  summary         NEPA  review
--------------------------------------------------------------------------------------------------------------------------------------------------------
141-326............  Virbac AH, Inc., 3200  RILEXINE (cephalexin)  Original approval for the              New   yes................  CE \1\
                      Meacham Blvd., Ft.     Chewable Tablets for   treatment of secondary            520.376
                      Worth, TX 76137.       Dogs.                  superficial bacterial
                                                                    pyoderma in dogs caused
                                                                    by susceptible strains of
                                                                    Staphylococcus
                                                                    pseudintermedius.
141-337............  Nexcyon                RECUVYRA (fentanyl)    Original approval for                  New   yes................  CE \1\
                      Pharmaceuticals,       Transdermal Solution.  control of postoperative          524.916
                      Inc., 644 W.                                  pain associated with
                      Washington Ave.,                              surgical procedures in
                      Madison, WI 53703.                            dogs.
141-338............  Novartis Animal        INTERCEPTOR SPECTRUM   Original approval for                  New   yes................  CE \1\
                      Health US, Inc.,       (milbemycin oxime/     prevention of heartworm          520.1445
                      3200 Northline Ave.,   praziquantel)          disease caused by
                      suite 300,             Chewable Tablets.      Dirofilaria immitis and
                      Greensboro, NC 27408.                         for the treatment and
                                                                    control of adult
                                                                    roundworm (Toxocara
                                                                    canis, Toxascaris
                                                                    leonina), adult hookworm
                                                                    (Ancylostoma caninum),
                                                                    adult whipworm (Trichuris
                                                                    vulpis), and adult
                                                                    tapeworm (Taenia
                                                                    pisiformis, Echinococcus
                                                                    multilocularis, and E.
                                                                    granulosus) infections in
                                                                    dogs and puppies two
                                                                    pounds of body weight or
                                                                    greater and six weeks of
                                                                    age and older.
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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 (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.

[[Page 47512]]

    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 and 524

    Animal drugs.

    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, and 524 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. In Sec.  510.600, in the table in paragraph (c)(1), alphabetically 
add an entry for ``Nexcyon Pharmaceuticals, Inc.''; and in the table in 
paragraph (c)(2), numerically add an entry for ``050929'' to 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
------------------------------------------------------------------------
 
                                * * * * *
Nexcyon Pharmaceuticals, Inc., 644 W. Washington Ave.,            050929
 Madison, WI 53703.........................................
 
                                * * * * *
------------------------------------------------------------------------

    (2) * * *

------------------------------------------------------------------------
           Drug labeler code                  Firm name and address
------------------------------------------------------------------------
 
                                * * * * *
050929.................................  Nexcyon Pharmaceuticals, Inc.,
                                          644 W. Washington Ave.,
                                          Madison, WI 53703
 
                                * * * * *
------------------------------------------------------------------------

PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS

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

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

0
4. Section 520.376 is added to read as follows:

Sec.  520.376  Cephalexin.

    (a) Specifications. Each chewable tablet contains 75, 150, 300, or 
600 milligrams (mg) cephalexin.
    (b) Sponsor. See No. 051311 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use--(1) Dogs--(i) Amount. Administer 22 mg per 
kilogram of body weight twice daily for 28 days.
    (ii) Indications for use. For the treatment of secondary 
superficial bacterial pyoderma in dogs caused by susceptible strains of 
Staphylococcus pseudintermedius.
    (iii) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.
    (2) [Reserved]

Sec.  520.1445  [Redesignated as Sec.  520.1441]

Sec.  520.1446  [Redesignated as Sec.  520.1443]

0
5. Redesignate Sec. Sec.  520.1445 and 520.1446 as Sec. Sec.  520.1441 
and 520.1443, respectively.

0
6. Revise the section heading of newly redesignated Sec.  520.1445 to 
read as follows:

Sec.  520.1441  Milbemycin oxime.

* * * * *

0
7. Revise the section heading of newly redesignated Sec.  520.1446 to 
read as follows:

Sec.  520.1443  Milbemycin oxime and lufenuron.

* * * * *

0
8. Add new Sec.  520.1445 to read as follows:

Sec.  520.1445  Milbemycin oxime and praziquantel.

    (a) Specifications. Each chewable tablet contains:
    (1) 2.3 milligrams (mg) milbemycin oxime and 22.8 mg praziquantel;
    (2) 5.75 mg milbemycin oxime and 57 mg praziquantel;
    (3) 11.5 mg milbemycin oxime and 114 mg praziquantel; or
    (4) 23 mg milbemycin oxime and 228 mg praziquantel.
    (b) Sponsor. See No. 058198 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use--(1) Dogs--(i) Amount. Administer orally, 
once a month, a minimum dosage of 0.23 mg per pound (mg/lb) of body 
weight (0.5 mg per kilogram (mg/kg)) milbemycin oxime and 2.28 mg/lb of 
body weight (5 mg/kg) praziquantel.
    (ii) Indications for use. For the prevention of heartworm disease 
caused by Dirofilaria immitis and for the treatment and control of 
adult roundworm (Toxocara canis, Toxascaris leonina), adult hookworm 
(Ancylostoma caninum), adult whipworm (Trichuris vulpis), and adult 
tapeworm (Taenia pisiformis, Echinococcus multilocularis, and E. 
granulosus) infections in dogs and puppies 2 pounds of body weight or 
greater and 6 weeks of age and older.
    (iii) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.
    (2) [Reserved]

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

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

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

0
10. Add Sec.  524.916 to read as follows:

Sec.  524.916  Fentanyl.

    (a) Specifications. Each milliliter of solution contains 50 
milligrams (mg) fentanyl.
    (b) Sponsor. See No. 050929 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use--(1) Dogs--(i) Amount. 1.2 mg/lb (2.7 mg/kg) 
applied topically to the dorsal scapular area 2 to 4 hours prior to 
surgery.
    (ii) Indications for use. For the control of postoperative pain 
associated with surgical procedures in dogs.
    (iii) Limitations. Fentanyl is a Class II controlled substance. 
Observe all ``black-box warnings'' on product labeling. Federal law 
restricts this drug to use by or on the order of a licensed 
veterinarian.
    (2) [Reserved]

    Dated: August 3, 2012.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2012-19498 Filed 8-8-12; 8:45 am]
BILLING CODE 4160-01-P