Oral Dosage Form New Animal Drugs; Milbemycin Oxime, Lufenuron, and Praziquantel, 4225 [2012-1744]
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Federal Register / Vol. 77, No. 18 / Friday, January 27, 2012 / Rules and Regulations
heartworm disease, for prevention and
control of fleas, and for the treatment
and control of various internal parasites
in dogs.
DATES: This rule is effective January 27,
§ 510.600 Names, addresses, and drug
2012.
labeler codes of sponsors of approved
applications.
FOR FURTHER INFORMATION CONTACT:
Steven Fleischer, Center for Veterinary
*
*
*
*
*
Medicine (HFV–110), Food and Drug
(c) * * *
Administration, 7500 Standish Pl.,
(1) * * *
Rockville, MD 20855, 240–276–8234,
Drug labeler
email: steven.fleischer@fda.hhs.gov.
Firm name and address
code
SUPPLEMENTARY INFORMATION: Novartis
Animal Health US, Inc., 3200 Northline
Ave., Suite 300, Greensboro, NC 27408,
*
*
*
*
*
filed NADA 141–333 that provides for
Fougera Pharmaceuticals,
Inc., P.O. Box 2006, 60
the veterinary prescription use of
Baylis Rd., Melville, NY
SENTINEL SPECTRUM (milbemycin
11747 ................................
025463 oxime/lufenuron/praziquantel) Tablets
for the prevention of heartworm disease,
*
*
*
*
*
for the prevention and control of flea
populations, and for the treatment and
(2) * * *
control of adult roundworm, adult
hookworm, adult whipworm, and adult
Drug labeler
Firm name and address
tapeworm infections in dogs and
code
puppies 2 pounds of body weight or
greater and 6 weeks of age and older.
*
*
*
*
*
The NADA is approved as of December
025463 ........ Fougera Pharmaceuticals,
8, 2011, and 21 CFR part 520 is
Inc., P.O. Box 2006, 60
amended by adding new § 520.1447 to
Baylis Rd., Melville, NY
reflect the approval.
11747.
A summary of safety and effectiveness
data and information submitted to
*
*
*
*
*
support approval of this application
may be seen in the Division of Dockets
Dated: January 24, 2012.
Management (HFA–305), Food and Drug
William T. Flynn,
Administration, 5630 Fishers Lane, Rm.
Acting Director, Center for Veterinary
1061, Rockville, MD 20852, between 9
Medicine.
a.m. and 4 p.m., Monday through
[FR Doc. 2012–1756 Filed 1–26–12; 8:45 am]
Friday.
BILLING CODE 4160–01–P
Under section 512(c)(2)(F)(ii) of the
Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 360b(c)(2)(F)(ii)), this
DEPARTMENT OF HEALTH AND
approval qualifies for 3 years of
HUMAN SERVICES
marketing exclusivity beginning on the
date of approval.
Food and Drug Administration
The Agency has determined under 21
CFR 25.33 that this action is of a type
21 CFR Part 520
that does not individually or
[Docket No. FDA–2011–N–0003]
cumulatively have a significant effect on
the human environment. Therefore,
Oral Dosage Form New Animal Drugs;
neither an environmental assessment
Milbemycin Oxime, Lufenuron, and
nor an environmental impact statement
Praziquantel
is required.
This rule does not meet the definition
AGENCY: Food and Drug Administration,
of ‘‘rule’’ in 5 U.S.C. 804(3)(A) because
HHS.
it is a rule of ‘‘particular applicability.’’
ACTION: Final rule.
Therefore, it is not subject to the
congressional review requirements in 5
SUMMARY: The Food and Drug
U.S.C. 801–808.
Administration (FDA) is amending the
animal drug regulations to reflect
List of Subjects in 21 CFR Part 520
approval of a new animal drug
Animal drugs.
application (NADA) filed by Novartis
Animal Health US, Inc. The NADA
Therefore, under the Federal Food,
provides for the veterinary prescription
Drug, and Cosmetic Act and under
use of milbemycin oxime, lufenuron,
authority delegated to the Commissioner
and praziquantel for the prevention of
of Food and Drugs and redelegated to
pmangrum on DSK3VPTVN1PROD with RULES
in paragraph (c)(2), revise the entry for
‘‘025463’’.
The addition and revision read as
follows:
VerDate Mar<15>2010
15:16 Jan 26, 2012
Jkt 226001
PO 00000
Frm 00023
Fmt 4700
Sfmt 9990
4225
the Center for Veterinary Medicine, 21
CFR part 520 is amended as follows:
PART 520—ORAL DOSAGE FORM
NEW ANIMAL DRUGS
1. The authority citation for 21 CFR
part 520 continues to read as follows:
■
Authority: 21 U.S.C. 360b.
■
2. Add § 520.1447 to read as follows:
§ 520.1447 Milbemycin oxime, lufenuron,
and praziquantel tablets.
(a) Specifications. Each tablet
contains:
(1) 2.3 milligrams (mg) milbemycin
oxime, 46 mg lufenuron, and 22.8 mg
praziquantel;
(2) 5.75 mg milbemycin oxime, 115
mg lufenuron, and 57 mg praziquantel;
(3) 11.5 mg milbemycin oxime, 230
mg lufenuron, and 114 mg praziquantel;
or
(4) 23 mg milbemycin oxime, 460 mg
lufenuron, and 228 mg praziquantel.
(b) Sponsor. See No. 058198 in
§ 510.600(c) of this chapter.
(c) [Reserved]
(d) Conditions of use—(1) Dogs—(i)
Amount. 0.5 mg milbemycin oxime, 10
mg lufenuron, and 5 mg of praziquantel
per kilogram of body weight, once a
month.
(ii) Indications for use. For the
prevention of heartworm disease caused
by Dirofilaria immitis; for the
prevention and control of flea
populations (Ctenocephalides felis); 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]
Dated: January 23, 2012.
William T. Flynn,
Acting Director, Center for Veterinary
Medicine.
[FR Doc. 2012–1744 Filed 1–26–12; 8:45 am]
BILLING CODE 4160–01–P
E:\FR\FM\27JAR1.SGM
27JAR1
]]>Agencies
[Federal Register Volume 77, Number 18 (Friday, January 27, 2012)]
[Rules and Regulations]
[Page 4225]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-1744]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 520
[Docket No. FDA-2011-N-0003]
Oral Dosage Form New Animal Drugs; Milbemycin Oxime, Lufenuron,
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 of a new animal drug application
(NADA) filed by Novartis Animal Health US, Inc. The NADA provides for
the veterinary prescription use of milbemycin oxime, lufenuron, and
praziquantel for the prevention of heartworm disease, for prevention
and control of fleas, and for the treatment and control of various
internal parasites in dogs.
DATES: This rule is effective January 27, 2012.
FOR FURTHER INFORMATION CONTACT: Steven Fleischer, Center for
Veterinary Medicine (HFV-110), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 240-276-8234, email:
steven.fleischer@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Novartis Animal Health US, Inc., 3200
Northline Ave., Suite 300, Greensboro, NC 27408, filed NADA 141-333
that provides for the veterinary prescription use of SENTINEL SPECTRUM
(milbemycin oxime/lufenuron/praziquantel) Tablets for the prevention of
heartworm disease, for the prevention and control of flea populations,
and for the treatment and control of adult roundworm, adult hookworm,
adult whipworm, and adult tapeworm infections in dogs and puppies 2
pounds of body weight or greater and 6 weeks of age and older. The NADA
is approved as of December 8, 2011, and 21 CFR part 520 is amended by
adding new Sec. 520.1447 to reflect the approval.
A summary of safety and effectiveness data and information
submitted to support approval of this application 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.
Under section 512(c)(2)(F)(ii) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(ii)), this approval qualifies for
3 years of marketing exclusivity beginning on the date of approval.
The Agency has determined under 21 CFR 25.33 that this action is of
a type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.
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 in 21 CFR Part 520
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 part 520 is
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. 520.1447 to read as follows:
Sec. 520.1447 Milbemycin oxime, lufenuron, and praziquantel tablets.
(a) Specifications. Each tablet contains:
(1) 2.3 milligrams (mg) milbemycin oxime, 46 mg lufenuron, and 22.8
mg praziquantel;
(2) 5.75 mg milbemycin oxime, 115 mg lufenuron, and 57 mg
praziquantel;
(3) 11.5 mg milbemycin oxime, 230 mg lufenuron, and 114 mg
praziquantel; or
(4) 23 mg milbemycin oxime, 460 mg lufenuron, and 228 mg
praziquantel.
(b) Sponsor. See No. 058198 in Sec. 510.600(c) of this chapter.
(c) [Reserved]
(d) Conditions of use--(1) Dogs--(i) Amount. 0.5 mg milbemycin
oxime, 10 mg lufenuron, and 5 mg of praziquantel per kilogram of body
weight, once a month.
(ii) Indications for use. For the prevention of heartworm disease
caused by Dirofilaria immitis; for the prevention and control of flea
populations (Ctenocephalides felis); 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]
Dated: January 23, 2012.
William T. Flynn,
Acting Director, Center for Veterinary Medicine.
[FR Doc. 2012-1744 Filed 1-26-12; 8:45 am]
BILLING CODE 4160-01-P
