Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications, 31586-31587 [E7-11002]
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31586
Federal Register / Vol. 72, No. 109 / Thursday, June 7, 2007 / Notices
which is typically a version of the drug
that was previously approved. Sponsors
of ANDAs do not have to repeat the
extensive clinical testing otherwise
necessary to gain approval of a new
drug application (NDA). The only
clinical data required in an ANDA are
data to show that the drug that is the
subject of the ANDA is bioequivalent to
the listed drug.
The 1984 amendments include what
is now section 505(j)(7) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C.
355(j)(7)), which requires FDA to
publish a list of all approved drugs.
FDA publishes this list as part of the
‘‘Approved Drug Products With
Therapeutic Equivalence Evaluations,’’
which is generally known as the
‘‘Orange Book.’’ Under FDA regulations,
drugs are withdrawn from the list if the
agency withdraws or suspends approval
of the drug’s NDA or ANDA for reasons
of safety or effectiveness or if FDA
determines that the listed drug was
withdrawn from sale for reasons of
safety or effectiveness (21 CFR 314.162).
Under 21 CFR 314.161(a)(1), the
agency must determine whether a listed
drug was withdrawn from sale for
reasons of safety or effectiveness before
an ANDA that refers to that listed drug
may be approved. FDA may not approve
an ANDA that does not refer to a listed
drug.
CEFOTAN (cefotetan disodium for
injection), equivalent 1 g base/vial and
2 g base/vial, is the subject of approved
NDA 50–588 held by AstraZeneca
Pharmaceuticals LP (AstraZeneca).
CEFOTAN (cefotetan disodium for
injection) is indicated for the
therapeutic treatment of urinary tract
infections, lower respiratory tract
infections, skin and skin structure
infections, gynecologic infections, intraabdominal infections, and bone and
joint infections when caused by
susceptible strains of the designated
organisms described in the labeling.
FDA approved the NDA for CEFOTAN
(cefotetan disodium for injection),
equivalent 1 g base/vial and 2 g base/
vial, on December 27, 1985. Beginning
with the October 2006 update, FDA has
listed CEFOTAN (cefotetan disodium
for injection), equivalent 1 g base/vial
and 2 g base/vial, in the ‘‘Discontinued
Drug Product List’’ of the Orange Book
because AstraZeneca notified FDA that
the product was no longer marketed.
B. Braun Medical Inc., submitted a
citizen petition dated May 10, 2006
(Docket No. 2006P–0201/CP1), under 21
CFR 10.30, requesting that the agency
determine whether CEFOTAN (cefotetan
disodium for injection), equivalent 1 g
base/vial and 2 g base/vial (NDA 50–
588) was withdrawn from sale for
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reasons of safety or effectiveness. After
considering the citizen petition
(including comments submitted) and
reviewing agency records, FDA has
determined that CEFOTAN (cefotetan
disodium for injection), equivalent 1 g
base/vial and 2 g base/vial, was not
withdrawn from sale for reasons of
safety or effectiveness. The petitioner
identified no data or other information
suggesting that CEFOTAN (cefotetan
disodium for injection), equivalent 1 g
base/vial and 2 g base/vial, was
withdrawn from sale as a result of safety
or effectiveness concerns. FDA has
independently evaluated relevant
literature and data for adverse event
reports and has found no information
that would indicate that CEFOTAN
(cefotetan disodium for injection),
equivalent 1 g base/vial and 2 g base/
vial, was withdrawn for reasons of
safety or effectiveness.
For the reasons outlined in this
document, FDA determines that
CEFOTAN (cefotetan disodium for
injection), equivalent 1 g base/vial and
2 g base/vial, was not withdrawn from
sale for reasons of safety or
effectiveness. Accordingly, the agency
will continue to list CEFOTAN
(cefotetan disodium for injection),
equivalent 1 g base/vial and 2 g base/
vial, in the ‘‘Discontinued Drug Product
List’’ section of the Orange Book. The
‘‘Discontinued Drug Product List’’
delineates, among other items, drug
products that have been discontinued
from marketing for reasons other than
safety or effectiveness. ANDAs that refer
to CEFOTAN (cefotetan disodium for
injection), equivalent 1 g base/vial and
2 g base/vial, may be approved by the
agency as long as they meet all relevant
legal and regulatory requirements for
approval of ANDAs. If FDA determines
that labeling for these drug products
should be revised to meet current
standards, the agency will advise ANDA
applicants to submit such labeling.
Dated: May 31, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket Nos. 2007M–0109, 2007M–0006,
2007M–0007, 2007M–0032, 2007M–0049,
2007M–0038, 2007M–0058, 2007M–0086,
2007M–0107, 2007M–0084, 2007M–0108]
Medical Devices; Availability of Safety
and Effectiveness Summaries for
Premarket Approval Applications
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is publishing a
list of premarket approval applications
(PMAs) that have been approved. This
list is intended to inform the public of
the availability of safety and
effectiveness summaries of approved
PMAs through the Internet and the
agency’s Division of Dockets
Management.
Submit written requests for
copies of summaries of safety and
effectiveness data to the Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, rm. 1061, Rockville, MD 20852.
Please cite the appropriate docket
number as listed in table 1 of this
document when submitting a written
request. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the summaries of safety and
effectiveness.
ADDRESSES:
FOR FURTHER INFORMATION CONTACT:
Thinh Nguyen, Center for Devices and
Radiological Health (HFZ–402), Food
and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850,
240–276–4010, ext. 152.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of January 30,
1998 (63 FR 4571), FDA published a
final rule that revised 21 CFR 814.44(d)
and 814.45(d) to discontinue individual
publication of PMA approvals and
denials in the Federal Register. Instead,
the agency now posts this information
on the Internet on FDA’s home page at
https://www.fda.gov. FDA believes that
this procedure expedites public
notification of these actions because
announcements can be placed on the
Internet more quickly than they can be
published in the Federal Register, and
FDA believes that the Internet is
accessible to more people than the
Federal Register.
In accordance with section 515(d)(4)
and (e)(2) of the Federal Food, Drug, and
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31587
Federal Register / Vol. 72, No. 109 / Thursday, June 7, 2007 / Notices
Cosmetic Act (the act) (21 U.S.C.
360e(d)(4) and (e)(2)), notification of an
order approving, denying, or
withdrawing approval of a PMA will
continue to include a notice of
opportunity to request review of the
order under section 515(g) of the act.
The 30-day period for requesting
reconsideration of an FDA action under
§ 10.33(b) (21 CFR 10.33(b)) for notices
announcing approval of a PMA begins
on the day the notice is placed on the
Internet. Section 10.33(b) provides that
FDA may, for good cause, extend this
30-day period. Reconsideration of a
denial or withdrawal of approval of a
PMA may be sought only by the
applicant; in these cases, the 30-day
period will begin when the applicant is
notified by FDA in writing of its
decision.
The regulations provide that FDA
publish a quarterly list of available
safety and effectiveness summaries of
PMA approvals and denials that were
announced during that quarter. The
following is a list of approved PMAs for
which summaries of safety and
effectiveness were placed on the
Internet from January 1, 2007, through
March 31, 2007. There were no denial
actions during this period. The list
provides the manufacturer’s name, the
product’s generic name or the trade
name, and the approval date.
TABLE 1.—LIST OF SAFETY AND EFFECTIVENESS SUMMARIES FOR APPROVED PMAS MADE AVAILABLE FROM JANUARY 1,
2007, THROUGH MARCH 31, 2007
PMA No./Docket No.
Applicant
Trade Name
Approval Date
P040051/2007M–0109
Stelkast Co.
STELKAST SURPASS ACETABULAR SYSTEM
May 12, 2006
P050037/2007M–0006
Bioform Medical, Inc.
RADIESSE 1.3 CC AND 0.3 CC
December 22, 2006
P050052/2007M–0007
Bioform Medical, Inc.
RADIESSE 1.3 CC AND 0.3 CC
December 22, 2006
P050018/2007M–0032
Angioscore, Inc.
ANGIOSCULPT SCORING BALLOON CATHETER
January 8, 2007
P060001/2007M–0049
EV3, Inc.
PROTEGE GPS AND PROTEGE RX CAROTID STENT
SYSTEMS
January 24, 2007
H060004/2007M–0038
Fujirebio Diagnostics,
Inc.
FUJIREBIO MESOMARK ASSAY
January 24, 2007
P050007(S1)/2007M–0058
Abbott Vascular Devices
STARCLOSE VASCULAR CLOSURE SYSTEM
February 2, 2007
P050013/2007M–0086
Tissue Seal, LLC.
HISTOACRYL & HISTOACRYL BLUE TOPICAL SKIN ADHESIVE
February 16, 2007
P980022(S15)/2007M–0107
Medtronic Minimed
GUARDIAN RT & PARADIGM REAL–TIME CONTIUOUS
GLUCOSE MONITORING SYSTEMS
March 8, 2007
P050053/2007M–0084
Medtronic Sofamor
Danek USA, Inc.
INFUSE BONE GRAFT
March 9, 2007
P060019/2007M–0108
Irvine Biomedical, Inc.
IBI THERAPY COOL PATH ABLATION CATHETER & IBI–
1500T9 RF ABLATION GENERATOR
March 16, 2007
II. Electronic Access
ACTION:
Persons with access to the Internet
may obtain the documents at https://
www.fda.gov/cdrh/pmapage.html.
The Food and Drug Administration
(FDA) is announcing an amendment to
the notice of meeting of the Science
Board to the Food and Drug
Administration (Science Board). This
meeting was originally announced in
the Federal Register of May 21, 2007 (72
FR 28499). The amendment is being
made to reflect a change in the Agenda
and Procedure portions of the
document. There are no other changes.
FOR FURTHER INFORMATION CONTACT:
˜
Carlos Pena, Office of the
Commissioner, Food and Drug
Administration (HF–33), 5600 Fishers
Lane, Rockville, Maryland, 20857, 301–
˜
827–6687, carlos.pena@fda.hhs.gov, or
FDA Advisory Committee Information
Line, 1–800–741–8138 (301–443–0572
in the Washington, DC area), code
3014512603. Please call the Information
Line for up-to-date information on this
meeting.
Dated: May 24, 2007.
Linda S. Kahan,
Deputy Director, Center for Devices and
Radiological Health.
[FR Doc. E7–11002 Filed 6–6–07; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
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[Docket No. 2007N–0208]
Science Board to the Food and Drug
Administration; Amendment of Notice
AGENCY:
Food and Drug Administration,
HHS.
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In the
Federal Register of May 21, 2007, FDA
announced that a meeting of the Science
Board would be held on June 14, 2007.
On page 28499, in the second and third
columns, the Agenda and Procedure
portions of document are amended to
read as follows:
Agenda: The Science Board will hear
about and discuss the agency’s
bioinformatics initiative and fellowship
program. The Science Board will hear
about and review the scientific validity
of the agency’s ‘‘Interim Melamine and
Analogues Safety/Risk Assessment’’
(https://www.cfsan.fda.gov/~lrd/
fr070530.html, Docket No. 2007N–
0208). The Science Board will then
continue its discussion of the review of
both the agency’s science programs and
the National Antimicrobial Resistance
Monitoring System (NARMS) Program,
from the March 31, 2006, Science Board
meeting. Discussions will first include a
SUPPLEMENTARY INFORMATION:
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]]>Agencies
[Federal Register Volume 72, Number 109 (Thursday, June 7, 2007)]
[Notices]
[Pages 31586-31587]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-11002]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket Nos. 2007M-0109, 2007M-0006, 2007M-0007, 2007M-0032, 2007M-
0049, 2007M-0038, 2007M-0058, 2007M-0086, 2007M-0107, 2007M-0084,
2007M-0108]
Medical Devices; Availability of Safety and Effectiveness
Summaries for Premarket Approval Applications
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is publishing a list of
premarket approval applications (PMAs) that have been approved. This
list is intended to inform the public of the availability of safety and
effectiveness summaries of approved PMAs through the Internet and the
agency's Division of Dockets Management.
ADDRESSES: Submit written requests for copies of summaries of safety
and effectiveness data to the Division of Dockets Management (HFA-305),
Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville,
MD 20852. Please cite the appropriate docket number as listed in table
1 of this document when submitting a written request. See the
SUPPLEMENTARY INFORMATION section for electronic access to the
summaries of safety and effectiveness.
FOR FURTHER INFORMATION CONTACT: Thinh Nguyen, Center for Devices and
Radiological Health (HFZ-402), Food and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850, 240-276-4010, ext. 152.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of January 30, 1998 (63 FR 4571), FDA
published a final rule that revised 21 CFR 814.44(d) and 814.45(d) to
discontinue individual publication of PMA approvals and denials in the
Federal Register. Instead, the agency now posts this information on the
Internet on FDA's home page at https://www.fda.gov. FDA believes that
this procedure expedites public notification of these actions because
announcements can be placed on the Internet more quickly than they can
be published in the Federal Register, and FDA believes that the
Internet is accessible to more people than the Federal Register.
In accordance with section 515(d)(4) and (e)(2) of the Federal
Food, Drug, and
[[Page 31587]]
Cosmetic Act (the act) (21 U.S.C. 360e(d)(4) and (e)(2)), notification
of an order approving, denying, or withdrawing approval of a PMA will
continue to include a notice of opportunity to request review of the
order under section 515(g) of the act. The 30-day period for requesting
reconsideration of an FDA action under Sec. 10.33(b) (21 CFR 10.33(b))
for notices announcing approval of a PMA begins on the day the notice
is placed on the Internet. Section 10.33(b) provides that FDA may, for
good cause, extend this 30-day period. Reconsideration of a denial or
withdrawal of approval of a PMA may be sought only by the applicant; in
these cases, the 30-day period will begin when the applicant is
notified by FDA in writing of its decision.
The regulations provide that FDA publish a quarterly list of
available safety and effectiveness summaries of PMA approvals and
denials that were announced during that quarter. The following is a
list of approved PMAs for which summaries of safety and effectiveness
were placed on the Internet from January 1, 2007, through March 31,
2007. There were no denial actions during this period. The list
provides the manufacturer's name, the product's generic name or the
trade name, and the approval date.
Table 1.--List of Safety and Effectiveness Summaries for Approved PMAs
Made Available From January 1, 2007, through March 31, 2007
------------------------------------------------------------------------
PMA No./Docket Approval
No. Applicant Trade Name Date
------------------------------------------------------------------------
P040051/2007M- Stelkast Co. STELKAST SURPASS May 12, 2006
0109 ACETABULAR SYSTEM
------------------------------------------------------------------------
P050037/2007M- Bioform RADIESSE 1.3 CC AND 0.3 December 22,
0006 Medical, Inc. CC 2006
------------------------------------------------------------------------
P050052/2007M- Bioform RADIESSE 1.3 CC AND 0.3 December 22,
0007 Medical, Inc. CC 2006
------------------------------------------------------------------------
P050018/2007M- Angioscore, ANGIOSCULPT SCORING January 8,
0032 Inc. BALLOON CATHETER 2007
------------------------------------------------------------------------
P060001/2007M- EV3, Inc. PROTEGE GPS AND PROTEGE January 24,
0049 RX CAROTID STENT SYSTEMS 2007
------------------------------------------------------------------------
H060004/2007M- Fujirebio FUJIREBIO MESOMARK ASSAY January 24,
0038 Diagnostics, 2007
Inc.
------------------------------------------------------------------------
P050007(S1)/ Abbott STARCLOSE VASCULAR February 2,
2007M-0058 Vascular CLOSURE SYSTEM 2007
Devices
------------------------------------------------------------------------
P050013/2007M- Tissue Seal, HISTOACRYL & HISTOACRYL February 16,
0086 LLC. BLUE TOPICAL SKIN 2007
ADHESIVE
------------------------------------------------------------------------
P980022(S15)/ Medtronic GUARDIAN RT & PARADIGM March 8,
2007M-0107 Minimed REAL-TIME CONTIUOUS 2007
GLUCOSE MONITORING
SYSTEMS
------------------------------------------------------------------------
P050053/2007M- Medtronic INFUSE BONE GRAFT March 9,
0084 Sofamor Danek 2007
USA, Inc.
------------------------------------------------------------------------
P060019/2007M- Irvine IBI THERAPY COOL PATH March 16,
0108 Biomedical, ABLATION CATHETER & IBI- 2007
Inc. 1500T9 RF ABLATION
GENERATOR
------------------------------------------------------------------------
II. Electronic Access
Persons with access to the Internet may obtain the documents at
https://www.fda.gov/cdrh/pmapage.html.
Dated: May 24, 2007.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. E7-11002 Filed 6-6-07; 8:45 am]
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