Oral Dosage Form New Animal Drugs; Firocoxib Tablets, 2808 [E8-730]
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2808
Federal Register / Vol. 73, No. 11 / Wednesday, January 16, 2008 / Rules and Regulations
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 520
Oral Dosage Form New Animal Drugs;
Firocoxib Tablets
AGENCY:
Food and Drug Administration,
HHS.
ebenthall on PRODPC61 with RULES
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 Merial
Ltd. The supplemental NADA provides
for veterinary prescription use of
firocoxib chewable tablets in dogs for
the control of postoperative pain and
inflammation associated with soft-tissue
surgery.
DATES: This rule is effective January 16,
2008.
FOR FURTHER INFORMATION CONTACT:
Melanie R. Berson, Center for Veterinary
Medicine (HFV–110), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 240–276–8337, email: melanie.berson@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Merial
Ltd., 3239 Satellite Blvd., Bldg. 500,
Duluth, GA 30096–4640, filed a
supplement to NADA 141–230 for
PREVICOX (firocoxib) Chewable
Tablets. The supplemental application
provides for the veterinary prescription
use of firocoxib chewable tablets in dogs
for the control of postoperative pain and
inflammation associated with soft-tissue
surgery. The NADA is approved as of
December 18, 2007, and the regulations
in 21 CFR 520.928 are 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.
Under section 512(c)(2)(F)(iii) of the
Federal Food, Drug, and Cosmetics Act
(21 U.S.C. 360b(c)(2)(F)(iii)), this
approval qualifies for 3 years of
marketing exclusivity beginning on the
date of approval.
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
VerDate Aug<31>2005
15:01 Jan 15, 2008
Jkt 214001
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 § 520.928, revise paragraphs
(c)(1) and (c)(2) to read as follows:
I
§ 520.928
Firocoxib tablets.
*
*
*
*
*
(c) * * *
(1) Amount. 5 mg/kg (2.27 mg/lb)
body weight. Administer once daily for
osteoarthritis. Administer
approximately 2 hours before soft-tissue
surgery.
(2) Indications for use. For the control
of pain and inflammation associated
with osteoarthritis and for the control of
postoperative pain and inflammation
associated with soft-tissue surgery.
*
*
*
*
*
Dated: January 4, 2008.
Bernadette Dunham,
Deputy Director, Center for Veterinary
Medicine.
[FR Doc. E8–730 Filed 1–15–08; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 522
Implantation or Injectable Dosage
Form New Animal Drugs; Flunixin
AGENCY:
Final rule.
Frm 00016
Fmt 4700
This rule is effective January 16,
2008.
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.
FOR FURTHER INFORMATION CONTACT:
Norbrook
Laboratories, Ltd., Station Works,
Newry BT35 6JP, Northern Ireland, filed
supplemental ANADA 200–308 that
provides for veterinary prescription use
of Flunixin Injection intravenously in
lactating dairy cattle for control of
pyrexia associated with acute bovine
mastitis. The supplemental ANADA is
approved as of December 19, 2007, and
the regulations are amended in 21 CFR
522.970 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 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 Subject in 21 CFR Part 522
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 522 is amended as follows:
I
SUMMARY: The Food and Drug
Administration (FDA) is amending the
animal drug regulations to reflect
approval of a supplemental abbreviated
PO 00000
DATES:
Food and Drug Administration,
HHS.
ACTION:
new animal drug application (ANADA)
filed by Norbrook Laboratories, Ltd. The
supplemental ANADA provides for the
veterinary prescription use of flunixin
meglumine solution by intravenous
injection in lactating dairy cattle for
control of pyrexia associated with acute
bovine mastitis.
Sfmt 4700
E:\FR\FM\16JAR1.SGM
16JAR1
]]>Agencies
[Federal Register Volume 73, Number 11 (Wednesday, January 16, 2008)]
[Rules and Regulations]
[Page 2808]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-730]
[[Page 2808]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 520
Oral Dosage Form New Animal Drugs; Firocoxib 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 Merial Ltd. The supplemental NADA provides
for veterinary prescription use of firocoxib chewable tablets in dogs
for the control of postoperative pain and inflammation associated with
soft-tissue surgery.
DATES: This rule is effective January 16, 2008.
FOR FURTHER INFORMATION CONTACT: Melanie R. Berson, Center for
Veterinary Medicine (HFV-110), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 240-276-8337, e-mail:
melanie.berson@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Merial Ltd., 3239 Satellite Blvd., Bldg.
500, Duluth, GA 30096-4640, filed a supplement to NADA 141-230 for
PREVICOX (firocoxib) Chewable Tablets. The supplemental application
provides for the veterinary prescription use of firocoxib chewable
tablets in dogs for the control of postoperative pain and inflammation
associated with soft-tissue surgery. The NADA is approved as of
December 18, 2007, and the regulations in 21 CFR 520.928 are 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.
Under section 512(c)(2)(F)(iii) of the Federal Food, Drug, and
Cosmetics Act (21 U.S.C. 360b(c)(2)(F)(iii)), this approval qualifies
for 3 years of marketing exclusivity beginning on the date of approval.
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.
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. 520.928, revise paragraphs (c)(1) and (c)(2) to read as
follows:
Sec. 520.928 Firocoxib tablets.
* * * * *
(c) * * *
(1) Amount. 5 mg/kg (2.27 mg/lb) body weight. Administer once daily
for osteoarthritis. Administer approximately 2 hours before soft-tissue
surgery.
(2) Indications for use. For the control of pain and inflammation
associated with osteoarthritis and for the control of postoperative
pain and inflammation associated with soft-tissue surgery.
* * * * *
Dated: January 4, 2008.
Bernadette Dunham,
Deputy Director, Center for Veterinary Medicine.
[FR Doc. E8-730 Filed 1-15-08; 8:45 am]
BILLING CODE 4160-01-S
