Oral Dosage Form New Animal Drugs; Clomipramine Tablets, 261-262 [E6-22509]
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Federal Register / Vol. 72, No. 2 / Thursday, January 4, 2007 / Rules and Regulations
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.
The agency has determined under 21
CFR 25.33(a)(1) 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.
*
*
*
*
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 and 522 are amended as
follows:
I
PART 510—NEW ANIMAL DRUGS
1. The authority citation for 21 CFR
part 510 continues to read as follows:
I
Authority: 21 U.S.C. 321, 331, 351, 352,
353, 360b, 371, 379e.
2. In § 510.600, in the table in
paragraph (c)(1), alphabetically add a
new entry for ‘‘Modern Veterinary
Therapeutics, LLC’’; and in the table in
paragraph (c)(2) numerically add a new
entry for ‘‘015914’’ to read as follows:
I
§ 510.600 Names, addresses, and drug
labeler codes of sponsors of approved
applications.
*
*
Firm name and address
Drug labeler
code
*
*
*
00:35 Jan 04, 2007
Jkt 211001
Food and Drug Administration
21 CFR Part 520
*
*
*
Modern Veterinary Therapeutics, LLC, 18301 SW.
86th Ave., Miami, FL
33157
*
*
*
4. Revise § 522.775 to read as follows:
Doxapram.
(a) Specifications. Each milliliter of
solution contains 20 milligrams (mg)
doxapram hydrochloride.
(b) Sponsor. See Nos. 000856 and
015914 in § 510.600(c) of this chapter.
(c) Conditions of use—(1) Amount.
For intravenous use in dogs and cats at
a dose of 21⁄2 to 5 mg per pound (/lb)
body weight in barbiturate anesthesia,
0.5 mg/lb in inhalation anesthesia; for
intravenous use in horses at 0.25 mg/lb
body weight in barbiturate anesthesia,
0.2 mg/lb in inhalation anesthesia, 0.25
mg/lb with chloral hydrate with or
without magnesium sulfate; for
subcutaneous, sublingual, or umbilical
vein administration in neonate puppies
at a dose rate of 1 to 5 mg; for
subcutaneous or sublingual use in
neonate kittens at 1 to 2 mg. Dosage may
be repeated in 15 to 20 minutes if
necessary.
(2) Indications for use. Administer to
dogs, cats, and horses to stimulate
respiration during and after general
anesthesia; or to speed awakening and
return of reflexes after anesthesia.
Administer to neonate dogs and cats to
initiate respiration following dystocia or
caesarean section; or to stimulate
respiration following dystocia or
caesarean section.
(3) Limitations. Federal law restricts
this drug to use by or on the order of
a licensed veterinarian.
*
PO 00000
Frm 00015
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Firm name and address
PART 522—IMPLANTATION OR
INJECTABLE DOSAGE FORM NEW
ANIMAL DRUGS
§ 522.775
Animal drugs.
pwalker on PROD1PC65 with RULES
*
015914
I
21 CFR Part 522
VerDate Aug<31>2005
*
(2) * * *
Drug labeler
code
Dated: December 19, 2006.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. E6–22510 Filed 12–29–06; 8:45 am]
BILLING CODE 4160–01–S
Authority: 21 U.S.C. 360b.
Administrative practice and
procedure, Animal drugs, Labeling,
Reporting and recordkeeping
requirements.
*
015914
3. The authority citation for 21 CFR
part 522 continues to read as follows:
21 CFR Part 510
*
*
(c) * * *
(1) * * *
Modern Veterinary Therapeutics, LLC, 18301 SW.
86th Ave., Miami, FL
33157.
*
*
*
Drug labeler
code
I
List of Subjects
*
Firm name and address
261
Fmt 4700
Sfmt 4700
Oral Dosage Form New Animal Drugs;
Clomipramine Tablets
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 supplemental new animal
drug application (NADA) filed by
Novartis Animal Health US, Inc. The
supplemental NADA adds a 5-milligram
tablet size of clomipramine
hydrochloride, used in dogs for
treatment of separation anxiety.
DATES: This rule is effective January 4,
2007.
FOR FURTHER INFORMATION CONTACT:
Melanie R. Berson, Center for Veterinary
Medicine (HFV–110), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 301–827–7540, email: melanie.berson@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Novartis
Animal Health US, Inc., 3200 Northline
Ave., suite 300, Greensboro, NC 27408,
filed a supplement to NADA 141–120
that provides for the veterinary
prescription use of CLOMICALM
(clomipramine hydrochloride) Tablets
for treatment of separation anxiety in
dogs. The supplement provides for a 5milligram tablet size of clomipramine
hydrochloride. The supplemental
NADA is approved as of November 22,
2006, and 21 CFR 520.455 is amended
to reflect the approval. The basis of
approval is discussed in the freedom of
information summary.
In accordance with the freedom of
information provisions of 21 CFR part
20 and 21 CFR 514.11(e)(2)(ii), 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.
FDA has determined under 21 CFR
25.33(a)(1) that this action is of a type
E:\FR\FM\04JAR1.SGM
04JAR1
262
Federal Register / Vol. 72, No. 2 / Thursday, January 4, 2007 / Rules and Regulations
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.
I 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
1. The authority citation for 21 CFR
part 520 continues to read as follows:
I
Authority: 21 U.S.C. 360b.
2. In § 520.455, revise the section
heading and paragraph (a) to read as
follows:
I
§ 520.455
Clomipramine tablets.
(a) Specifications. Each tablet
contains 5, 20, 40, or 80 milligrams (mg)
clomipramine hydrochloride.
*
*
*
*
*
Dated: December 19, 2006.
Steven D. Vaughn,
Director, Office of New Animal Drug
Evaluation, Center for Veterinary Medicine.
[FR Doc. E6–22509 Filed 1–3–07; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
used in swine drinking water for the
treatment of respiratory disease.
DATES:
Joan
C. Gotthardt, Center for Veterinary
Medicine (HFV–130), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 301–827–7571, email: joan.gotthardt@fda.hhs.gov.
FOR FURTHER INFORMATION CONTACT:
ScheringPlough Animal Health Corp., 556 Morris
Ave., Summit NJ 07901, filed a
supplement to NADA 141–206 for
NUFLOR (florfenicol) 2.3% Concentrate
Solution used to make medicated
drinking water for administration to
swine for the treatment of respiratory
disease associated with several bacterial
pathogens. The supplemental NADA
revises the nomenclature for a
respiratory pathogen in the label claim.
The supplemental NADA is approved as
of December 8, 2006, and the
regulations in 21 CFR 520.955 are
amended to reflect the approval.
Approval of this supplemental NADA
did not require review of additional
safety or effectiveness data or
information. Therefore, a freedom of
information summary is not required.
The agency has determined under 21
CFR 25.33(a)(1) 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.
SUPPLEMENTARY INFORMATION:
List of Subjects in 21 CFR Part 520
Food and Drug Administration
Animal drugs.
21 CFR Part 520
Food and Drug Administration,
HHS.
ACTION:
Final rule.
The Food and Drug
Administration (FDA) is amending the
animal drug regulations to reflect
approval of a supplemental new animal
drug application (NADA) filed by
Schering-Plough Animal Health Corp.
The supplemental NADA revises the
nomenclature for a respiratory pathogen
in the label claim for florfenicol when
pwalker on PROD1PC65 with RULES
SUMMARY:
VerDate Aug<31>2005
00:35 Jan 04, 2007
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:
I
Oral Dosage Form New Animal Drugs;
Florfenicol
AGENCY:
This rule is effective January 4,
2007.
Jkt 211001
PART 520—ORAL DOSAGE FORM
NEW ANIMAL DRUGS
1. The authority citation for 21 CFR
part 520 continues to read as follows:
I
Authority: 21 U.S.C. 360b.
§ 520.955
[Amended]
2. In paragraph (d)(2) of § 520.955,
remove the words ‘‘Type 2’’.
I
PO 00000
Frm 00016
Fmt 4700
Sfmt 4700
Dated: December 21, 2006.
Steven D. Vaughn,
Director, Office of New Animal Drug
Evaluation, Center for Veterinary Medicine.
[FR Doc. E6–22516 Filed 12–29–06; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 520
Oral Dosage Form New Animal Drugs;
Dirlotapide
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 Pfizer, Inc.
The NADA provides for the veterinary
prescription use of dirlotapide solution
in dogs for the management of obesity.
DATES: This rule is effective January 4,
2007.
FOR FURTHER INFORMATION CONTACT:
Melanie R. Berson, Center for Veterinary
Medicine (HFV–110), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 301–827–7540, email: melanie.berson@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Pfizer,
Inc., 235 East 42d St., New York, NY
10017–5755, filed NADA 141–260 for
SLENTROL (dirlotapide) Oral Solution.
The NADA provides for the veterinary
prescription use of dirlotapide solution
in dogs for the management of obesity.
The application is approved as of
December 12, 2006, and the regulations
are amended in 21 CFR part 520 by
adding new § 520.666 to reflect the
approval. The basis of approval is
discussed in the freedom of information
summary.
In accordance with the freedom of
information provisions of 21 CFR part
20 and 21 CFR 514.11(e)(2)(ii), 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)(i) of the
Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 360b(c)(2)(F)(i)), this
approval qualifies for 5 years of
E:\FR\FM\04JAR1.SGM
04JAR1
]]>Agencies
[Federal Register Volume 72, Number 2 (Thursday, January 4, 2007)]
[Rules and Regulations]
[Pages 261-262]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-22509]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 520
Oral Dosage Form New Animal Drugs; Clomipramine Tablets
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 supplemental new animal drug
application (NADA) filed by Novartis Animal Health US, Inc. The
supplemental NADA adds a 5-milligram tablet size of clomipramine
hydrochloride, used in dogs for treatment of separation anxiety.
DATES: This rule is effective January 4, 2007.
FOR FURTHER INFORMATION CONTACT: Melanie R. Berson, Center for
Veterinary Medicine (HFV-110), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-827-7540, e-mail:
melanie.berson@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Novartis Animal Health US, Inc., 3200
Northline Ave., suite 300, Greensboro, NC 27408, filed a supplement to
NADA 141-120 that provides for the veterinary prescription use of
CLOMICALM (clomipramine hydrochloride) Tablets for treatment of
separation anxiety in dogs. The supplement provides for a 5-milligram
tablet size of clomipramine hydrochloride. The supplemental NADA is
approved as of November 22, 2006, and 21 CFR 520.455 is amended to
reflect the approval. The basis of approval is discussed in the freedom
of information summary.
In accordance with the freedom of information provisions of 21 CFR
part 20 and 21 CFR 514.11(e)(2)(ii), 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.
FDA has determined under 21 CFR 25.33(a)(1) that this action is of
a type
[[Page 262]]
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.
0
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. In Sec. 520.455, revise the section heading and paragraph (a) to
read as follows:
Sec. 520.455 Clomipramine tablets.
(a) Specifications. Each tablet contains 5, 20, 40, or 80
milligrams (mg) clomipramine hydrochloride.
* * * * *
Dated: December 19, 2006.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary
Medicine.
[FR Doc. E6-22509 Filed 1-3-07; 8:45 am]
BILLING CODE 4160-01-S
