[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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Rules and Regulations
Federal Register
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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
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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.
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\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