Implantation or Injectable Dosage Form New Animal Drugs; Dexmedetomidine, 263 [E6-22508]
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Federal Register / Vol. 72, No. 2 / Thursday, January 4, 2007 / Rules and Regulations
marketing exclusivity beginning
December 12, 2006.
The agency has determined under 21
CFR 25.33(d)(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.
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:
I
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. Section 520.666 is added to read as
follows:
I
§ 520.666
Dirlotapide.
pwalker on PROD1PC65 with RULES
(a) Specifications. Each milliliter (mL)
of solution contains 5 milligrams (mg)
dirlotapide.
(b) Sponsor. See No. 000069 in
§ 510.600(c) of this chapter.
(c) Conditions of use in dogs—(1)
Amount. The initial dosage is 0.01 mL/
kg (0.0045 mL/lb) body weight for the
first 14 days. After the first 14 days of
treatment, the dose volume is doubled
to 0.02 mL/kg (0.009 mL/lb) body
weight for the next 14 days (days 15 to
28 of treatment). Dogs should be
weighed monthly and the dose volume
adjusted every month, as necessary, to
maintain a target percent weight loss
until the desired weight is achieved.
(2) Indications for use. For the
management of obesity.
(3) Limitations. Federal law restricts
this drug to use by or on the order of
a licensed veterinarian.
Dated: December 20, 2006.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. E6–22542 Filed 1–3–07; 8:45 am]
BILLING CODE 4160–01–S
VerDate Aug<31>2005
00:35 Jan 04, 2007
Jkt 211001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 522
Implantation or Injectable Dosage
Form New Animal Drugs;
Dexmedetomidine
AGENCY:
Food and Drug Administration,
approval qualifies for 3 years of
marketing exclusivity beginning
December 1, 2006.
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 Parts 522
HHS.
ACTION:
Animal drugs.
Final rule.
The Food and Drug
Administration (FDA) is amending the
animal drug regulations to reflect
approval of an original new animal drug
application (NADA) filed by Orion
Corp. The NADA provides for veterinary
prescription use of dexmedetomidine
hydrochloride injectable solution as a
sedative, analgesic, and preanesthetic in
dogs.
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: Orion
Corp., Orionintie 1, 02200 Espoo,
Finland, filed NADA 141–267 for
DEXDOMITOR (dexmedetomidine
hydrochloride). The NADA provides for
the veterinary prescription use of
dexmedetomidine hydrochloride
injectable solution as a sedative,
analgesic, and preanesthetic in dogs.
The application is approved as of
December 1, 2006, and 21 CFR part 522
is amended by adding new § 522.558 to
reflect the approval.
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.
The agency has determined under
§ 25.33(d)(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.
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
SUMMARY:
PO 00000
Frm 00017
Fmt 4700
263
Sfmt 4700
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 522 is amended as follows:
I
PART 522—IMPLANTATION OR
INJECTABLE DOSAGE FORM NEW
ANIMAL DRUGS
1. The authority citation for 21 CFR
part 522 continues to read as follows:
I
Authority: 21 U.S.C. 360b.
I
2. Add § 522.558 to read as follows:
§ 522.558
Dexmedetomidine.
(a) Specifications. Each milliliter of
solution contains 10 milligrams (mg)
dexmedetomidine hydrochloride.
(b) Sponsor. See No. 052483 in
§ 510.600(c) of this chapter.
(c) Conditions of use in dogs—(1)
Indications for use and amount—(i) For
use as a sedative and analgesic in dogs
to facilitate clinical examinations,
clinical procedures, minor surgical
procedures, and minor dental
procedures, administer 375 micrograms
(µg) per square meter (/m2) of body
surface area by intravenous injection or
500 µg/m2 of body surface area by
intramuscular injection.
(ii) For use as a preanesthetic to
general anesthesia, administer 125 µg/
m2 of body surface area or 375 µg/m2 of
body surface area by intramuscular
injection.
(2) Limitations. Federal law restricts
this drug to use by or on the order of
a licensed veterinarian.
Dated: December 19, 2006.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. E6–22508 Filed 1–3–07; 8:45 am]
BILLING CODE 4160–01–S
E:\FR\FM\04JAR1.SGM
04JAR1
]]>Agencies
[Federal Register Volume 72, Number 2 (Thursday, January 4, 2007)]
[Rules and Regulations]
[Page 263]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-22508]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 522
Implantation or Injectable Dosage Form New Animal Drugs;
Dexmedetomidine
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 an original new animal drug
application (NADA) filed by Orion Corp. The NADA provides for
veterinary prescription use of dexmedetomidine hydrochloride injectable
solution as a sedative, analgesic, and preanesthetic in dogs.
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: Orion Corp., Orionintie 1, 02200 Espoo,
Finland, filed NADA 141-267 for DEXDOMITOR (dexmedetomidine
hydrochloride). The NADA provides for the veterinary prescription use
of dexmedetomidine hydrochloride injectable solution as a sedative,
analgesic, and preanesthetic in dogs. The application is approved as of
December 1, 2006, and 21 CFR part 522 is amended by adding new Sec.
522.558 to reflect the approval.
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.
The agency has determined under Sec. 25.33(d)(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.
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 December 1, 2006.
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 Parts 522
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 522 is
amended as follows:
PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
0
1. The authority citation for 21 CFR part 522 continues to read as
follows:
Authority: 21 U.S.C. 360b.
0
2. Add Sec. 522.558 to read as follows:
Sec. 522.558 Dexmedetomidine.
(a) Specifications. Each milliliter of solution contains 10
milligrams (mg) dexmedetomidine hydrochloride.
(b) Sponsor. See No. 052483 in Sec. 510.600(c) of this chapter.
(c) Conditions of use in dogs--(1) Indications for use and amount--
(i) For use as a sedative and analgesic in dogs to facilitate clinical
examinations, clinical procedures, minor surgical procedures, and minor
dental procedures, administer 375 micrograms ([micro]g) per square
meter (/m\2\) of body surface area by intravenous injection or 500
[micro]g/m\2\ of body surface area by intramuscular injection.
(ii) For use as a preanesthetic to general anesthesia, administer
125 [micro]g/m\2\ of body surface area or 375 [micro]g/m\2\ of body
surface area by intramuscular injection.
(2) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
Dated: December 19, 2006.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. E6-22508 Filed 1-3-07; 8:45 am]
BILLING CODE 4160-01-S
