Apothecon et al.; Withdrawal of Approval of 103 New Drug Applications and 35 Abbreviated New Drug Applications; Correction, 64951 [2011-26967]
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Federal Register / Vol. 76, No. 202 / Wednesday, October 19, 2011 / Notices
Dated: October 14, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–27020 Filed 10–18–11; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0002]
Cellular, Tissue and Gene Therapies
Advisory Committee; Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
emcdonald on DSK5VPTVN1PROD with NOTICES
ACTION:
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This notice announces a forthcoming
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(FDA). The meeting will be open to the
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and Gene Therapies Advisory
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Date and Time: The meeting will be
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5200. For those unable to attend in
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2011, the link for the Web cast is
available at https://fda.yorkcast.com/
webcast/Viewer/?peid=041ef376b14
f4599be568b1b2893e85d1d.
Contact Person: Gail Dapolito or
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Agenda: On November 17, 2011,the
committee will discuss Apligraf (Oral),
Organogenesis, Inc., BLA 125400, for
the treatment of surgically created
gingival and alveolar mucosal surface
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64951
ucm111462.htm for procedures on
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Notice of this meeting is given under
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Dated: October 12, 2011.
Jill Hartzler Warner,
Acting Associate Commissioner for Special
Medical Programs.
[FR Doc. 2011–27038 Filed 10–18–11; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–N–0026]
Apothecon et al.; Withdrawal of
Approval of 103 New Drug
Applications and 35 Abbreviated New
Drug Applications; Correction
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice; correction.
The Food and Drug
Administration (FDA) is correcting a
notice that appeared in the Federal
Register of February 11, 2009 (74 FR
6896). The document withdrew
approval of 103 new drug applications
(NDAs) and 35 abbreviated new drug
applications (ANDAs) from multiple
applicants. The document inadvertently
withdrew approval of NDA 50–435 for
GEOCILLIN (carbenicillin indanyl
sodium) Tablets held by Pfizer, Inc., 235
East 42d St., New York, NY 10017. FDA
confirms that approval of NDA 50–435
is still in effect.
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
Florine Purdie, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 6366,
Silver Spring, MD 20993–0002, 301–
796–3601.
In FR Doc.
E9–2901, appearing on page 6896, in the
Federal Register of Wednesday,
February 11, 2009, the following
correction is made:
1. On page 6900, in the table, the
entry for NDA 50–435 is removed.
SUPPLEMENTARY INFORMATION:
Dated: September 30, 2011.
Janet Woodcock,
Director, Center for Drug Evaluation and
Research.
[FR Doc. 2011–26967 Filed 10–18–11; 8:45 am]
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E:\FR\FM\19OCN1.SGM
19OCN1
Agencies
[Federal Register Volume 76, Number 202 (Wednesday, October 19, 2011)]
[Notices]
[Page 64951]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-26967]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2009-N-0026]
Apothecon et al.; Withdrawal of Approval of 103 New Drug
Applications and 35 Abbreviated New Drug Applications; Correction
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; correction.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is correcting a notice
that appeared in the Federal Register of February 11, 2009 (74 FR
6896). The document withdrew approval of 103 new drug applications
(NDAs) and 35 abbreviated new drug applications (ANDAs) from multiple
applicants. The document inadvertently withdrew approval of NDA 50-435
for GEOCILLIN (carbenicillin indanyl sodium) Tablets held by Pfizer,
Inc., 235 East 42d St., New York, NY 10017. FDA confirms that approval
of NDA 50-435 is still in effect.
FOR FURTHER INFORMATION CONTACT: Florine Purdie, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 6366, Silver Spring, MD 20993-0002, 301-
796-3601.
SUPPLEMENTARY INFORMATION: In FR Doc. E9-2901, appearing on page 6896,
in the Federal Register of Wednesday, February 11, 2009, the following
correction is made:
1. On page 6900, in the table, the entry for NDA 50-435 is removed.
Dated: September 30, 2011.
Janet Woodcock,
Director, Center for Drug Evaluation and Research.
[FR Doc. 2011-26967 Filed 10-18-11; 8:45 am]
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