[Federal Register Volume 75, Number 225 (Tuesday, November 23, 2010)]
[Notices]
[Page 71450]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-29522]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0001]
Oncologic Drugs Advisory Committee; Amendment of Notice
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing an
amendment to the notice of a meeting of the Oncologic Drugs Advisory
Committee. This meeting was announced in the Federal Register of
October 19, 2010 (75 FR 64314). The amendment is being made to reflect
changes in the Date and Time, Agenda, and Procedure portions of the
document. We also are postponing a session regarding biologics license
application (BLA) 125377, with the proposed trade name Yervoy
(ipilimumab), manufactured by Bristol-Myers Squibb Co. The proposed
indication (use) for this product is for the treatment of advanced
melanoma in patients who have received prior therapy. This portion of
the meeting has been postponed due to the need to complete the review
of additional data submitted by the applicant. Future meeting dates may
be announced in the Federal Register.
FOR FURTHER INFORMATION CONTACT: Nicole Vesely, 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, e-mail: [email protected], or FDA
Advisory Committee Information Line, 1-800-741-8138, 301-443-0572 in
the Washington, DC area, code 301-451-2542. Please call the Information
Line for up-to-date information on this meeting.
SUPPLEMENTARY INFORMATION: In the Federal Register of October 19, 2010
(75 FR 64314), FDA announced that a meeting of the Oncologic Drugs
Advisory Committee would be held on December 2, 2010. On page 64314, in
the first column, the Date and Time portion of the document is changed
to read as follows:
Date and Time: The meeting will be held on December 2, 2010, from 8
a.m. to 12:30 p.m.
On page 64314, in the second column, the Agenda portion of the
document is changed to read as follows:
Agenda: On December 2, 2010, the committee will discuss new drug
application (NDA) 022-405, with the proposed trade name Zictifa
(vandetanib) Tablets, manufactured by iPR Pharmaceuticals, Inc.,
represented by AstraZeneca Pharmaceuticals LP (authorized U.S. agent).
The proposed indication (use) for this product is for the treatment of
patients with unresectable (non-operable) locally advanced or
metastatic medullary thyroid cancer.
On page 64314, in the second column, the third sentence in the
Procedure portion of the document is changed to read as follows:
Procedure: Oral presentations from the public will be scheduled
between approximately 10:30 a.m. and 11:30 a.m.
This notice is issued under the Federal Advisory Committee Act (5
U.S.C. app. 2) and 21 CFR part 14, relating to the advisory committees.
Dated: November 17, 2010.
Joanne Less,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2010-29522 Filed 11-22-10; 8:45 am]
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