[Federal Register Volume 80, Number 42 (Wednesday, March 4, 2015)]
[Notices]
[Pages 11680-11681]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-04395]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2015-N-0001]
Endocrinologic and Metabolic Drugs Advisory Committee; Notice of
Meeting
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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This notice announces a forthcoming meeting of a public advisory
committee of the Food and Drug Administration (FDA). The meeting will
be open to the public.
Name of Committee: Endocrinologic and Metabolic Drugs Advisory
Committee.
General Function of the Committee: To provide advice and
recommendations to the Agency on FDA's regulatory issues.
Date and Time: The meeting will be held on April 14, 2015, from
7:30 a.m. to 5:15 p.m.
[[Page 11681]]
Location: FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31
Conference Center, the Great Room (Rm. 1503), Silver Spring, MD 20993-
0002. Answers to commonly asked questions including information
regarding special accommodations due to a disability, visitor parking,
and transportation may be accessed at: http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm.
Contact Person: Philip Bautista, Center for Drug Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
31, Rm. 2417, Silver Spring, MD 20993-0002, 301-796-9001, FAX: 301-847-
8533, [email protected], or FDA Advisory Committee Information Line, 1-
800-741-8138 (301-443-0572 in the Washington, DC area). A notice in the
Federal Register about last minute modifications that impact a
previously announced advisory committee meeting cannot always be
published quickly enough to provide timely notice. Therefore, you
should always check the Agency's Web site at http://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to the appropriate
advisory committee meeting link, or call the advisory committee
information line to learn about possible modifications before coming to
the meeting.
Agenda: During the morning session, the committee will discuss the
results of the cardiovascular outcomes trial (CVOT), Saxagliptin
Assessment of Vascular Outcomes Recorded in Patients with Diabetes
Mellitus, for new drug application (NDA) 22350, Onglyza (saxagliptin)
and NDA 200678, Kombiglyze XR (saxagliptin and metformin HCl extended-
release) tablets manufactured/marketed by AstraZeneca AB.
During the afternoon session, the committee will discuss the
results of the CVOT, Examination of Cardiovascular Outcomes with
Alogliptin versus Standard of Care, for NDA 22271, Nesina (ALOGLIPTIN);
NDA 022426, Oseni (ALOGLIPTIN and PIOGLITAZONE); and NDA 203414, Kazano
(ALOGLIPTIN and METFORMIN) tablets marketed by Takeda Pharmaceutical
U.S.A., Inc.
Saxagliptin and ALOGLIPTIN are dipeptidyl peptidase-4 inhibitors,
both indicated as an adjunct to diet and exercise to improve glycemic
control in adults with type 2 diabetes mellitus. Both CVOTs were
submitted in accordance with the 2008 FDA Draft Guidance, ``Diabetes
Mellitus--Evaluating Cardiovascular Risk in New Antidiabetic Therapies
to Treat Type 2 Diabetes,'' to demonstrate that a new antidiabetic
therapy to treat type 2 diabetes is not associated with an unacceptable
increase in cardiovascular risk.
FDA intends to make background material available to the public no
later than 2 business days before the meeting. If FDA is unable to post
the background material on its Web site prior to the meeting, the
background material will be made publicly available at the location of
the advisory committee meeting, and the background material will be
posted on FDA's Web site after the meeting. Background material is
available at http://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee meeting
link.
Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the committee.
Written submissions may be made to the contact person on or before
March 31, 2015. Oral presentations from the public will be scheduled
between approximately 10:10 a.m. to 10:40 a.m., and 3:30 p.m. to 4 p.m.
Those individuals interested in making formal oral presentations should
notify the contact person and submit a brief statement of the general
nature of the evidence or arguments they wish to present, the names and
addresses of proposed participants, and an indication of the
approximate time requested to make their presentation on or before
March 23, 2015. Time allotted for each presentation may be limited. If
the number of registrants requesting to speak is greater than can be
reasonably accommodated during the scheduled open public hearing
session, FDA may conduct a lottery to determine the speakers for the
scheduled open public hearing session. The contact person will notify
interested persons regarding their request to speak by March 24, 2015.
Persons attending FDA's advisory committee meetings are advised
that the Agency is not responsible for providing access to electrical
outlets.
FDA welcomes the attendance of the public at its advisory committee
meetings and will make every effort to accommodate persons with
physical disabilities or special needs. If you require special
accommodations due to a disability, please contact Philip Bautista at
least 7 days in advance of the meeting.
FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our Web site at http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures
on public conduct during advisory committee meetings.
Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).
Dated: February 26, 2015.
Jill Hartzler Warner,
Associate Commissioner for Special Medical Programs.
[FR Doc. 2015-04395 Filed 3-3-15; 8:45 am]
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