Oral Dosage Form New Animal Drugs; Fluoxetine, 6463 [E7-2172]
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Federal Register / Vol. 72, No. 28 / Monday, February 12, 2007 / Rules and Regulations
V–75 [Corrected]
From Morgantown, WV; Bellaire, OH;
Briggs, OH; DRYER, OH; INT DRYER 325°
and Waterville, OH, 062° radials. The
airspace within Canada is excluded.
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Issued in Washington, DC, on February 2,
2007.
Edith V. Parish,
Manager, Airspace and Rules.
[FR Doc. E7–2229 Filed 2–9–07; 8:45 am]
BILLING CODE 4910–13–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 520
Oral Dosage Form New Animal Drugs;
Fluoxetine
AGENCY:
Food and Drug Administration,
HHS.
erjones on PRODPC74 with RULES
ACTION:
Final rule.
List of Subjects in 21 CFR Part 520
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 Elanco
Animal Health. The NADA provides for
veterinary prescription use of fluoxetine
hydrochloride chewable tablets for the
treatment of canine separation anxiety.
DATES: This rule is effective February
12, 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: Elanco
Animal Health, A Division of Eli Lilly
& Co., Lilly Corporate Center,
Indianapolis, IN 46285, filed NADA 141
272 that provides for veterinary
prescription use of RECONCILE
(fluoxetine hydrochloride) Chewable
Tablets for the treatment of canine
separation anxiety in conjunction with
a behavior modification plan. The
NADA is approved as of January 19,
2007, and the regulations in part 520 (21
CFR part 520) are amended by adding
new § 520.980 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
VerDate Aug<31>2005
15:23 Feb 09, 2007
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
marketing exclusivity beginning January
19, 2007.
FDA 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.
Jkt 211001
Animal drugs.
Therefore, under the Federal Food,
Drug, and Cosmetic Act and under the
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.
I
2. Add § 520.980 to read as follows:
§ 520.980
Fluoxetine.
(a) Specifications. Each chewable
tablet contains 8, 16, 32, or 64
milligrams (mg) fluoxetine
hydrochloride.
(b) Sponsor. See No. 000986 in
§ 510.600 of this chapter.
(c) Conditions of use in dogs—(1)
Amount. 1 to 2 mg per kilogram body
weight once daily.
(2) Indications for use. For the
treatment of canine separation anxiety
in conjunction with a behavior
modification plan.
(3) Limitations. Federal law restricts
this drug to use by or on the order of
a licensed veterinarian.
Dated: January 31, 2007.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. E7–2172 Filed 2–9–07; 8:45 am]
BILLING CODE 4160–01–S
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6463
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 524
Ophthalmic and Topical Dosage Form
New Animal Drugs; Ivermectin Topical
Solution
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 abbreviated
new animal drug application (ANADA)
filed by Norbrook Laboratories, Ltd. The
supplemental ANADA adds claims for
persistent effectiveness against various
species of external and internal
parasites when cattle are treated with a
topical solution of ivermectin.
DATES: This rule is effective February
12, 2007.
FOR FURTHER INFORMATION CONTACT: John
K. Harshman, Center for Veterinary
Medicine (HFV–104), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 301–827–0169, email: john.harshman@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Norbrook
Laboratories, Ltd., Station Works,
Newry BT35 6JP, Northern Ireland, filed
a supplement to ANADA 200–272 for
Ivermectin Pour-On for Cattle. The
supplemental ANADA adds claims for
persistent effectiveness against various
species of external and internal
parasites that were approved for the
pioneer product with 3 years of
marketing exclusivity (69 FR 501,
January 6, 2004). The supplemental
ANADA is approved as of January 19,
2007, and 21 CFR 524.1193 is amended
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.
FDA 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.
E:\FR\FM\12FER1.SGM
12FER1
]]>Agencies
[Federal Register Volume 72, Number 28 (Monday, February 12, 2007)]
[Rules and Regulations]
[Page 6463]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-2172]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 520
Oral Dosage Form New Animal Drugs; Fluoxetine
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 Elanco Animal Health. The NADA provides for veterinary
prescription use of fluoxetine hydrochloride chewable tablets for the
treatment of canine separation anxiety.
DATES: This rule is effective February 12, 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: Elanco Animal Health, A Division of Eli
Lilly & Co., Lilly Corporate Center, Indianapolis, IN 46285, filed NADA
141 272 that provides for veterinary prescription use of RECONCILE
(fluoxetine hydrochloride) Chewable Tablets for the treatment of canine
separation anxiety in conjunction with a behavior modification plan.
The NADA is approved as of January 19, 2007, and the regulations in
part 520 (21 CFR part 520) are amended by adding new Sec. 520.980 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 marketing exclusivity beginning January 19, 2007.
FDA 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.
0
Therefore, under the Federal Food, Drug, and Cosmetic Act and under the
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. 520.980 to read as follows:
Sec. 520.980 Fluoxetine.
(a) Specifications. Each chewable tablet contains 8, 16, 32, or 64
milligrams (mg) fluoxetine hydrochloride.
(b) Sponsor. See No. 000986 in Sec. 510.600 of this chapter.
(c) Conditions of use in dogs--(1) Amount. 1 to 2 mg per kilogram
body weight once daily.
(2) Indications for use. For the treatment of canine separation
anxiety in conjunction with a behavior modification plan.
(3) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
Dated: January 31, 2007.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. E7-2172 Filed 2-9-07; 8:45 am]
BILLING CODE 4160-01-S
