Third Annual Sentinel Initiative Public Workshop, 76018 [2010-30562]
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76018
Federal Register / Vol. 75, No. 234 / Tuesday, December 7, 2010 / Notices
Restoration Act of 1984 (Pub. L. 98–417)
(the 1984 amendments), which
authorized the approval of duplicate
versions of drug products approved
under an ANDA procedure. ANDA
applicants must, with certain
exceptions, show that the drug for
which they are seeking approval
contains the same active ingredient in
the same strength and dosage form as
the ‘‘listed drug,’’ which is a version of
the drug that was previously approved.
ANDA applicants 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 known generally as the
‘‘Orange Book.’’ Under FDA regulations,
drugs are removed 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was withdrawn from sale for reasons of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 § 314.161(a)(1) (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withdrawn from sale for reasons of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.
GLEEVEC (imatinib mesylate)
Capsules, 50 mg and 100 mg, are the
subject of NDA 21–335, held by
Novartis Pharmaceutical Corp., and
initially approved on May 10, 2001.
GLEEVEC is a protein-tyrosine kinase
inhibitor used in the treatment of a
variety of malignancies, including Ph+
chronic myeloid leukemia and acute
lymphoblastic leukemia,
myelodysplastic/myeloproliferative
diseases, aggressive systemic
mastocytosis, hypereosinophilic
syndrome, chronic eosinophilic
leukemia, dermatofibrosarcoma
protuberans, and gastrointestinal
stromal tumors. FDA has moved
GLEEVEC (imatinib mesylate) Capsules,
50 mg and 100 mg, to the ‘‘Discontinued
Drug Product List’’ section of the Orange
Book.
Hyman, Phelps & McNamara, PC,
submitted a citizen petition dated June
VerDate Mar<15>2010
18:39 Dec 06, 2010
Jkt 223001
3, 2010 (Docket No. FDA–2010–P–
0275), under 21 CFR 10.30, requesting
that the Agency determine whether
GLEEVEC (imatinib mesylate) Capsules,
50 mg and 100 mg, were withdrawn
from sale for reasons of safety or
effectiveness.
After considering the citizen petition
and reviewing Agency records, FDA has
determined under § 314.161 that
GLEEVEC (imatinib mesylate) Capsules,
50 mg and 100 mg were not withdrawn
for reasons of safety or effectiveness.
The petitioner has identified no data or
other information suggesting that
GLEEVEC (imatinib mesylate) Capsules,
50 mg and 100 mg, were withdrawn for
reasons of safety or effectiveness. We
have carefully reviewed our files for
records concerning the withdrawal of
GLEEVEC (imatinib mesylate) capsules,
50 mg and 100 mg, from sale. We have
also independently evaluated relevant
literature and data for possible
postmarketing adverse events and have
found no information that would
indicate that these products were
withdrawn from sale for reasons of
safety or effectiveness.
Accordingly, the Agency will
continue to list GLEEVEC (imatinib
mesylate) Capsules, 50 mg and 100 mg,
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 GLEEVEC (imatinib mesylate)
Capsules, 50 mg and 100 mg, may be
approved by the Agency as long as they
meet all other legal and regulatory
requirements for the 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: December 1, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010–30570 Filed 12–6–10; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0001]
Third Annual Sentinel Initiative Public
Workshop
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
PO 00000
Notice of public workshop.
Frm 00067
Fmt 4703
Sfmt 9990
The Food and Drug Administration
(FDA) is announcing the following
public workshop: Third Annual
Sentinel Initiative Public Workshop.
Hosted by the Engelberg Center for
Health Care Reform at The Brookings
Institution, this 1-day public workshop
will bring together the stakeholder
community for a productive discussion
on a variety of topics in active medical
product surveillance, including an
update on Mini-Sentinel and related
activities, near-term plans for FDA’s
Sentinel Initiative, and opportunities for
coordination with other U.S.
Department of Health and Human
Services efforts that use distributed
systems of automated health care data.
Date and Time: The public workshop
will be held on January 12, 2011, from
8:30 a.m. to 4:30 p.m.
Location: The public workshop will
be held at the Renaissance Dupont
Hotel, 1143 New Hampshire Ave. NW.,
Washington, DC 20037.
Contact: Kayla Garvin, Center for
Drug Evaluation and Research, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 6331,
Silver Spring, MD 20993, 301–796–
7578, e-mail:
sentinelinitiative@fda.hhs.gov.
Registration: To attend the public
workshop, please register at https://
guest.cvent.com/d/hdq5r4/1Q. When
registering, provide the following
information: Your name, title, company
or organization (if applicable), address,
phone number, and e-mail address.
There is no fee to register for the public
workshop, but because seating is
limited, registration will be on a firstcome, first-served basis. A 1-hour lunch
break is scheduled; however, food will
not be provided. There are multiple
restaurants within walking distance of
the hotel where attendees can get food.
If you need special accommodations
due to a disability, please contact The
Brookings Institution event coordinator
at 202–797–4391 or e-mail:
sentinelevent@brookings.edu at least 7
days in advance.
Meeting Materials: Please be advised
that as soon as workshop materials are
available, they will be accessible at The
Brookings Institution events Web site at
https://www.brookings.edu//health/
events.
Dated: December 1, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010–30562 Filed 12–6–10; 8:45 am]
BILLING CODE 4160–01–P
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07DEN1
]]>Agencies
[Federal Register Volume 75, Number 234 (Tuesday, December 7, 2010)]
[Notices]
[Page 76018]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-30562]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0001]
Third Annual Sentinel Initiative Public Workshop
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public workshop.
-----------------------------------------------------------------------
The Food and Drug Administration (FDA) is announcing the following
public workshop: Third Annual Sentinel Initiative Public Workshop.
Hosted by the Engelberg Center for Health Care Reform at The Brookings
Institution, this 1-day public workshop will bring together the
stakeholder community for a productive discussion on a variety of
topics in active medical product surveillance, including an update on
Mini-Sentinel and related activities, near-term plans for FDA's
Sentinel Initiative, and opportunities for coordination with other U.S.
Department of Health and Human Services efforts that use distributed
systems of automated health care data.
Date and Time: The public workshop will be held on January 12,
2011, from 8:30 a.m. to 4:30 p.m.
Location: The public workshop will be held at the Renaissance
Dupont Hotel, 1143 New Hampshire Ave. NW., Washington, DC 20037.
Contact: Kayla Garvin, Center for Drug Evaluation and Research,
Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm.
6331, Silver Spring, MD 20993, 301-796-7578, e-mail:
sentinelinitiative@fda.hhs.gov.
Registration: To attend the public workshop, please register at
https://guest.cvent.com/d/hdq5r4/1Q. When registering, provide the
following information: Your name, title, company or organization (if
applicable), address, phone number, and e-mail address. There is no fee
to register for the public workshop, but because seating is limited,
registration will be on a first-come, first-served basis. A 1-hour
lunch break is scheduled; however, food will not be provided. There are
multiple restaurants within walking distance of the hotel where
attendees can get food. If you need special accommodations due to a
disability, please contact The Brookings Institution event coordinator
at 202-797-4391 or e-mail: sentinelevent@brookings.edu at least 7 days
in advance.
Meeting Materials: Please be advised that as soon as workshop
materials are available, they will be accessible at The Brookings
Institution events Web site at https://www.brookings.edu//health/events.
Dated: December 1, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-30562 Filed 12-6-10; 8:45 am]
BILLING CODE 4160-01-P
