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31586 Federal Register / Vol. 72, No.

109 / Thursday, June 7, 2007 / Notices

which is typically a version of the drug reasons of safety or effectiveness. After DEPARTMENT OF HEALTH AND
that was previously approved. Sponsors considering the citizen petition HUMAN SERVICES
of ANDAs do not have to repeat the (including comments submitted) and
extensive clinical testing otherwise reviewing agency records, FDA has Food and Drug Administration
necessary to gain approval of a new determined that CEFOTAN (cefotetan [Docket Nos. 2007M–0109, 2007M–0006,
drug application (NDA). The only disodium for injection), equivalent 1 g 2007M–0007, 2007M–0032, 2007M–0049,
clinical data required in an ANDA are base/vial and 2 g base/vial, was not 2007M–0038, 2007M–0058, 2007M–0086,
data to show that the drug that is the withdrawn from sale for reasons of 2007M–0107, 2007M–0084, 2007M–0108]
subject of the ANDA is bioequivalent to safety or effectiveness. The petitioner
the listed drug. Medical Devices; Availability of Safety
identified no data or other information
The 1984 amendments include what and Effectiveness Summaries for
is now section 505(j)(7) of the Federal suggesting that CEFOTAN (cefotetan Premarket Approval Applications
Food, Drug, and Cosmetic Act (21 U.S.C. disodium for injection), equivalent 1 g
355(j)(7)), which requires FDA to base/vial and 2 g base/vial, was AGENCY: Food and Drug Administration,
publish a list of all approved drugs. withdrawn from sale as a result of safety HHS.
FDA publishes this list as part of the or effectiveness concerns. FDA has ACTION: Notice.
‘‘Approved Drug Products With independently evaluated relevant
literature and data for adverse event SUMMARY: The Food and Drug
Therapeutic Equivalence Evaluations,’’
which is generally known as the reports and has found no information Administration (FDA) is publishing a
‘‘Orange Book.’’ Under FDA regulations, that would indicate that CEFOTAN list of premarket approval applications
drugs are withdrawn from the list if the (cefotetan disodium for injection), (PMAs) that have been approved. This
agency withdraws or suspends approval list is intended to inform the public of
equivalent 1 g base/vial and 2 g base/
of the drug’s NDA or ANDA for reasons the availability of safety and
vial, was withdrawn for reasons of
of safety or effectiveness or if FDA effectiveness summaries of approved
safety or effectiveness.
determines that the listed drug was PMAs through the Internet and the
For the reasons outlined in this agency’s Division of Dockets
withdrawn from sale for reasons of
safety or effectiveness (21 CFR 314.162). document, FDA determines that Management.
Under 21 CFR 314.161(a)(1), the CEFOTAN (cefotetan disodium for ADDRESSES: Submit written requests for
agency must determine whether a listed injection), equivalent 1 g base/vial and copies of summaries of safety and
drug was withdrawn from sale for 2 g base/vial, was not withdrawn from effectiveness data to the Division of
reasons of safety or effectiveness before sale for reasons of safety or Dockets Management (HFA–305), Food
an ANDA that refers to that listed drug effectiveness. Accordingly, the agency and Drug Administration, 5630 Fishers
may be approved. FDA may not approve will continue to list CEFOTAN Lane, rm. 1061, Rockville, MD 20852.
an ANDA that does not refer to a listed (cefotetan disodium for injection), Please cite the appropriate docket
drug. equivalent 1 g base/vial and 2 g base/ number as listed in table 1 of this
CEFOTAN (cefotetan disodium for vial, in the ‘‘Discontinued Drug Product document when submitting a written
injection), equivalent 1 g base/vial and List’’ section of the Orange Book. The request. See the SUPPLEMENTARY
2 g base/vial, is the subject of approved ‘‘Discontinued Drug Product List’’ INFORMATION section for electronic
NDA 50–588 held by AstraZeneca delineates, among other items, drug access to the summaries of safety and
Pharmaceuticals LP (AstraZeneca). products that have been discontinued effectiveness.
CEFOTAN (cefotetan disodium for from marketing for reasons other than
injection) is indicated for the FOR FURTHER INFORMATION CONTACT:
safety or effectiveness. ANDAs that refer Thinh Nguyen, Center for Devices and
therapeutic treatment of urinary tract
to CEFOTAN (cefotetan disodium for Radiological Health (HFZ–402), Food
infections, lower respiratory tract
infections, skin and skin structure injection), equivalent 1 g base/vial and and Drug Administration, 9200
infections, gynecologic infections, intra- 2 g base/vial, may be approved by the Corporate Blvd., Rockville, MD 20850,
abdominal infections, and bone and agency as long as they meet all relevant 240–276–4010, ext. 152.
joint infections when caused by legal and regulatory requirements for SUPPLEMENTARY INFORMATION:
susceptible strains of the designated approval of ANDAs. If FDA determines
that labeling for these drug products I. Background
organisms described in the labeling.
FDA approved the NDA for CEFOTAN should be revised to meet current In the Federal Register of January 30,
(cefotetan disodium for injection), standards, the agency will advise ANDA 1998 (63 FR 4571), FDA published a
equivalent 1 g base/vial and 2 g base/ applicants to submit such labeling. final rule that revised 21 CFR 814.44(d)
vial, on December 27, 1985. Beginning Dated: May 31, 2007.
and 814.45(d) to discontinue individual
with the October 2006 update, FDA has publication of PMA approvals and
Jeffrey Shuren, denials in the Federal Register. Instead,
listed CEFOTAN (cefotetan disodium
for injection), equivalent 1 g base/vial Assistant Commissioner for Policy. the agency now posts this information
and 2 g base/vial, in the ‘‘Discontinued [FR Doc. E7–10959 Filed 6–6–07; 8:45 am] on the Internet on FDA’s home page at
Drug Product List’’ of the Orange Book BILLING CODE 4160–01–S http://www.fda.gov. FDA believes that
because AstraZeneca notified FDA that this procedure expedites public
the product was no longer marketed. notification of these actions because
B. Braun Medical Inc., submitted a announcements can be placed on the
citizen petition dated May 10, 2006 Internet more quickly than they can be
(Docket No. 2006P–0201/CP1), under 21 published in the Federal Register, and
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CFR 10.30, requesting that the agency FDA believes that the Internet is
determine whether CEFOTAN (cefotetan accessible to more people than the
disodium for injection), equivalent 1 g Federal Register.
base/vial and 2 g base/vial (NDA 50– In accordance with section 515(d)(4)
588) was withdrawn from sale for and (e)(2) of the Federal Food, Drug, and

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Federal Register / Vol. 72, No. 109 / Thursday, June 7, 2007 / Notices 31587

Cosmetic Act (the act) (21 U.S.C. Internet. Section 10.33(b) provides that PMA approvals and denials that were
360e(d)(4) and (e)(2)), notification of an FDA may, for good cause, extend this announced during that quarter. The
order approving, denying, or 30-day period. Reconsideration of a following is a list of approved PMAs for
withdrawing approval of a PMA will denial or withdrawal of approval of a which summaries of safety and
continue to include a notice of PMA may be sought only by the effectiveness were placed on the
opportunity to request review of the applicant; in these cases, the 30-day Internet from January 1, 2007, through
order under section 515(g) of the act. period will begin when the applicant is March 31, 2007. There were no denial
The 30-day period for requesting notified by FDA in writing of its actions during this period. The list
reconsideration of an FDA action under decision. provides the manufacturer’s name, the
§ 10.33(b) (21 CFR 10.33(b)) for notices The regulations provide that FDA product’s generic name or the trade
announcing approval of a PMA begins publish a quarterly list of available
name, and the approval date.
on the day the notice is placed on the safety and effectiveness summaries of

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 January 24, 2007

H060004/2007M–0038 Fujirebio Diagnostics, 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 AD- February 16, 2007

P980022(S15)/2007M–0107 Medtronic Minimed GUARDIAN RT & PARADIGM REAL–TIME CONTIUOUS March 8, 2007

P050053/2007M–0084 Medtronic Sofamor INFUSE BONE GRAFT March 9, 2007

Danek USA, Inc.

P060019/2007M–0108 Irvine Biomedical, Inc. IBI THERAPY COOL PATH ABLATION CATHETER & IBI– March 16, 2007


Federal Register of May 21, 2007, FDA
Persons with access to the Internet The Food and Drug Administration announced that a meeting of the Science
may obtain the documents at http:// (FDA) is announcing an amendment to Board would be held on June 14, 2007.
www.fda.gov/cdrh/pmapage.html. the notice of meeting of the Science
On page 28499, in the second and third
Dated: May 24, 2007. Board to the Food and Drug
columns, the Agenda and Procedure
Linda S. Kahan, Administration (Science Board). This
portions of document are amended to
meeting was originally announced in
Deputy Director, Center for Devices and
the Federal Register of May 21, 2007 (72 read as follows:
Radiological Health.
FR 28499). The amendment is being Agenda: The Science Board will hear
[FR Doc. E7–11002 Filed 6–6–07; 8:45 am] about and discuss the agency’s
made to reflect a change in the Agenda
and Procedure portions of the bioinformatics initiative and fellowship
document. There are no other changes. program. The Science Board will hear
FOR FURTHER INFORMATION CONTACT: about and review the scientific validity
Carlos Peña, Office of the of the agency’s ‘‘Interim Melamine and
Commissioner, Food and Drug Analogues Safety/Risk Assessment’’
Food and Drug Administration Administration (HF–33), 5600 Fishers (http://www.cfsan.fda.gov/~lrd/
Lane, Rockville, Maryland, 20857, 301– fr070530.html, Docket No. 2007N–
827–6687, carlos.peña@fda.hhs.gov, or 0208). The Science Board will then
[Docket No. 2007N–0208]
FDA Advisory Committee Information continue its discussion of the review of
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Science Board to the Food and Drug Line, 1–800–741–8138 (301–443–0572 both the agency’s science programs and
Administration; Amendment of Notice in the Washington, DC area), code the National Antimicrobial Resistance
3014512603. Please call the Information Monitoring System (NARMS) Program,
AGENCY: Food and Drug Administration, Line for up-to-date information on this from the March 31, 2006, Science Board
HHS. meeting. meeting. Discussions will first include a

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