Oral Dosage Form New Animal Drugs; Carprofen, 51995 [E6-14508]
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Federal Register / Vol. 71, No. 170 / Friday, September 1, 2006 / Rules and Regulations
the words ‘‘FAA Order 7400.9N’’ and
adding, in their place, the words ‘‘FAA
Order 7400.9P.’’
§ 71.901
[Amended]
10. Paragraph (a) of section 71.901 is
amended by removing the words ‘‘FAA
Order 7400.9N’’ and adding, in their
place, the words ‘‘FAA Order 7400.9P.’’
I
Issued in Washington, DC, on July 27,
2006.
Edith V. Parish,
Manager, Airspace and Rules.
[FR Doc. E6–12434 Filed 8–31–06; 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;
Carprofen
AGENCY:
rwilkins on PROD1PC63 with RULES
List of Subjects in 21 CFR Part 520
Animal drugs.
Food and Drug Administration,
HHS.
ACTION:
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.
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
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 IMPAX Laboratories, Inc. The
supplemental ANADA provides for
veterinary prescription use of carprofen
caplets in dogs for the control of
postoperative pain associated with soft
tissue and orthopedic surgeries.
DATES: This rule is effective September
1, 2006.
FOR FURTHER INFORMATION CONTACT: John
K. Harshman, Center for Veterinary
Medicine (HFV–104), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 240–276–9808, email: john.harshman@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: IMPAX
Laboratories, Inc., 30831 Huntwood
Ave., Hayward, CA 94544, filed a
supplement to ANADA 200–366 for
NOVOX (carprofen) caplets which are
approved for veterinary prescription use
in dogs for the relief of pain and
inflammation associated with
osteoarthritis (70 FR 30625, May 27,
2005). The supplement provides for use
of NOVOX caplets for the control of
postoperative pain associated with soft
tissue and orthopedic surgeries. The
supplemental ANADA is approved as of
July 27, 2006, and 21 CFR 520.309 is
amended to reflect the approval.
In accordance with the freedom of
information provisions of 21 CFR part
VerDate Aug<31>2005
16:15 Aug 31, 2006
Jkt 208001
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 § 520.309, remove paragraphs
(d)(2)(i) and (d)(2)(ii), and revise
paragraphs (b)(2) and (d)(2) to read as
follows:
I
§ 520.309
Carprofen.
*
*
*
*
*
(b) * * *
(2) No. 000115 for use of product
described in paragraph (a)(1) as in
paragraph (d) of this section.
*
*
*
*
*
(d) * * *
(2) Indications for use. For the relief
of pain and inflammation associated
with osteoarthritis and for the control of
postoperative pain associated with soft
tissue and orthopedic surgeries.
*
*
*
*
*
Dated: August 18, 2006.
Steven D. Vaughn,
Director, Office of New Animal Drug
Evaluation, Center for Veterinary Medicine.
[FR Doc. E6–14508 Filed 8–31–06; 8:45 am]
BILLING CODE 4160–01–S
PO 00000
Frm 00019
Fmt 4700
Sfmt 4700
51995
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 522
Implantation or Injectable Dosage
Form New Animal Drugs; Lincomycin
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 abbreviated new animal
drug application (ANADA) filed by
Cross Vetpharm Group Ltd. The
ANADA provides for the use of
lincomycin injectable solution in swine
for the treatment of infectious arthritis
and mycoplasma pneumonia.
DATES: This rule is effective September
1, 2006.
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: Cross
Vetpharm Group Ltd., Broomhill Rd.,
Tallaght, Dublin 24, Ireland, filed
ANADA 200–368 that provides for use
of LINCOMED 100 (lincomycin
hydrochloride) and LINCOMED 300
(lincomycin hydrochloride) in swine for
the treatment of infectious arthritis and
mycoplasma pneumonia. Cross
Vetpharm Group Ltd.’s LINCOMED 100
and LINCOMED 300 are approved as
generic copies of LINCOMIX 100
Injectable and LINCOMIX 300
Injectable, sponsored by Pharmacia &
Upjohn Co., a Division of Pfizer, Inc.,
under NADA 034 025. The ANADA is
approved as of July 27, 2006, and the
regulations are amended in § 522.1260
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.
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
E:\FR\FM\01SER1.SGM
01SER1
]]>Agencies
[Federal Register Volume 71, Number 170 (Friday, September 1, 2006)]
[Rules and Regulations]
[Page 51995]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-14508]
=======================================================================
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 520
Oral Dosage Form New Animal Drugs; Carprofen
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 IMPAX Laboratories, Inc. The
supplemental ANADA provides for veterinary prescription use of
carprofen caplets in dogs for the control of postoperative pain
associated with soft tissue and orthopedic surgeries.
DATES: This rule is effective September 1, 2006.
FOR FURTHER INFORMATION CONTACT: John K. Harshman, Center for
Veterinary Medicine (HFV-104), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 240-276-9808, e-mail:
john.harshman@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: IMPAX Laboratories, Inc., 30831 Huntwood
Ave., Hayward, CA 94544, filed a supplement to ANADA 200-366 for NOVOX
(carprofen) caplets which are approved for veterinary prescription use
in dogs for the relief of pain and inflammation associated with
osteoarthritis (70 FR 30625, May 27, 2005). The supplement provides for
use of NOVOX caplets for the control of postoperative pain associated
with soft tissue and orthopedic surgeries. The supplemental ANADA is
approved as of July 27, 2006, and 21 CFR 520.309 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.
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.
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. 520.309, remove paragraphs (d)(2)(i) and (d)(2)(ii), and
revise paragraphs (b)(2) and (d)(2) to read as follows:
Sec. 520.309 Carprofen.
* * * * *
(b) * * *
(2) No. 000115 for use of product described in paragraph (a)(1) as
in paragraph (d) of this section.
* * * * *
(d) * * *
(2) Indications for use. For the relief of pain and inflammation
associated with osteoarthritis and for the control of postoperative
pain associated with soft tissue and orthopedic surgeries.
* * * * *
Dated: August 18, 2006.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary
Medicine.
[FR Doc. E6-14508 Filed 8-31-06; 8:45 am]
BILLING CODE 4160-01-S
