74 FR 234 pgs. 64701-64702 - Oncologic Drugs Advisory Committee; Amendment of Notice
Type: NOTICEVolume: 74Number: 234Pages: 64701 - 64702
Docket number: [Docket No. FDA-2009-N-0664]
FR document: [FR Doc. E9-29208 Filed 12-7-09; 8:45 am]
Agency: Health and Human Services Department
Sub Agency: Food and Drug Administration
Official PDF Version: PDF Version
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2009-N-0664]
Oncologic Drugs Advisory Committee; Amendment of Notice
AGENCY:
Food and Drug Administration, HHS.
ACTION:
Notice.
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 November 17, 2009 (74 FR 59195). The amendment is being made to reflect a change in the Date and Time , Agenda , and Procedure portions of the document. We also are cancelling a session regarding supplemental new drug application (sNDA) 022-059/S-007, TYKERB (lapatinib) tablets, by SmithKline Beecham Ltd. d/b/a GlaxoSmithKline. This portion of the meeting has been cancelled because the issues for which FDA was seeking the scientific input of the Committee have been resolved.
FOR FURTHER INFORMATION CONTACT:
Nicole Vesely, Center for Drug Evaluation and Research (HFD-21), Food and Drug Administration, 5600 Fishers Lane, (for express delivery, 5630 Fishers Lane, rm. 1093), Rockville, MD 20857, 301-827-6793, FAX: 301-827-6776, e-mail: nicole.vesely@fda.hhs.gov , or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington DC area), code 3014512542. Please call the Information Line for up-to-date information on this meeting.
SUPPLEMENTARY INFORMATION:
In the Federal Register of November 17, 2009 (74 FR 59195), FDA announced that a meeting of the Oncologic Drugs Advisory Committee would be held on December 16, 2009. On page 59195, 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 16, 2009, from 9 a.m. to 3 p.m.
On page 59195, in the second column, the Agenda portion of the document is changed to read as follows:
Agenda : On December 16, 2009, the committee will discuss supplemental new drug application (sNDA) 021-743/S-016, TARCEVA (erlotinib) tablets, by OSI Pharmaceuticals, Inc. The proposed indication (use) for this product is first-line maintenance, monotherapy (first-choice, single drug) treatment in patients with a form of lung cancer called non-small cell lung cancer (NSCLC) that is either locally advanced (has spread regionally within the lung and/or within chest lymph nodes) or metastatic (has spread beyond the lung), and who have not progressed (including those patients with stable disease) on first-line treatment with platinum-based chemotherapy (a regimen including a platinum drug (cisplatin or carboplatin) plus another chemotherapy drug).
On page 59195, in the third 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 1 p.m. to 2 p.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: December 3, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9-29208 Filed 12-7-09; 8:45 am]
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