FDAAdvisoryCommittee.com to Webcast Dec. 1-2 Reviews of Proctor & Gamble's Sexual Dysfunction Drug Intrinsa, Ilex' Clolar for Leukemia, and Inex/Enzon's Marqibo for Lymphoma.CHEVY CHASE, Md. -- Breakthrough FDAAdvisoryCommittee.com Webcasts on Dec 1-2 will provide live audio/video access to Food and Drug Administration committee reviews of three new drugs: Ilex' Clolar (Leukemia), Inex/Enzon's Marqibo (Hodgkin's Lymphoma); and Proctor & Gamble's Intrinsa (female sexual dysfunction sexual dysfunction Inability to experience arousal or achieve sexual satisfaction under ordinary circumstances, as a result of psychological or physiological problems. ). Dec. 1, 2004 FDA Oncologic Drugs Advisory Committee Webcast 8:00 a.m. EST www.FDAAdvisoryCommittee.com Watch live on Dec. 1 as FDA's Oncologic Drugs Advisory Committee decides whether to recommend approval of two new drugs, including a product that would be the first in more than 10 years with original labeling for pediatric pediatric /pe·di·at·ric/ (pe?de-at´rik) pertaining to the health of children. pe·di·at·ric adj. Of or relating to pediatrics. leukemia. Ilex' Clolar is undergoing priority review by FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. and is indicated for treatment of refractory or relapsed acute lymphocytic leukemia acute lymphocytic leukemia n. See acute lymphoblastic leukemia. acute lymphocytic leukemia Acute lymphoblastic leukemia, ALL A malignant lymphoproliferative process that commonly affects children and young adults (ALL) and acute myeloid leukemia myeloid leukemia n. See myelogenous leukemia. (AML AML - A Manufacturing Language ) in pediatric patients. The second drug to be reviewed Dec. 1 is Inex/Enzon's Marqibo, indicated for treatment of relapsed aggressive non-Hodgkin's lymphoma non-Hodg·kin's lymphoma n. Any of various malignant lymphomas characterized by the absence of Reed-Sternberg cells. Non-Hodgkin's lymphoma in patients previously treated with at least two combination chemotherapy regimens. Dec. 2, 2004 FDA Reproductive Health Drugs Advisory Committee Webcast 8:00 a.m. EST www.FDAAdvisoryCommittee.com On Dec. 2, find out firsthand if FDA's Reproductive Health Drugs Advisory Committee recommends approval of the first treatment for female sexual dysfunction, Proctor & Gamble's Intrinsa. Intrinsa is a transdermal testosterone patch indicated for the treatment of hypoactive sexual desire disorder in surgically menopausal women receiving concomitant estrogen therapy. Watch FDAAdvisoryCommittee.com's high-quality audio/video webcasts for complete gavel-to-gavel coverage, including: --Company presentations with slides of clinical trial data --FDA scientific and statistical reviews --Committee deliberations and recommendations To register for the Dec. 1 and Dec. 2 webcasts, please visit www.FDAAdvisoryCommittee.com. The meetings can be watched live or in a post-meeting archive format. Or bring a group together for a live videoconferencing feed from FDAAdvisoryCommittee.com. Videoconference viewers receive a free DVD DVD: see digital versatile disc. DVD in full digital video disc or digital versatile disc Type of optical disc. The DVD represents the second generation of compact-disc (CD) technology. or videotape recording of the meeting. DVDs and videotapes also are available for individual sale. To order videoconferencing, videotapes or DVDs, call 800-627-8171 or email webcasthelp@fdcreports.com. And sign up for FDAAdvisoryCommittee.com's FREE email alert service to receive the most up-to-date advisory committee news and information from the editors of "The Pink Sheet." Sign up for your no-cost, no-obligation subscription at www.FDAAdvisoryCommittee.com. FDAAdvisoryCommittee.com is produced by FDC FDC - Floppy Disk Controller Reports: a division of the Elsevier Company. Elsevier is a world-leading publisher of scientific, technical and medical information products and services. Working in partnership with the global science and health communities, the company publishes more than 1,800 journals and 2,200 new books per year, in addition to offering a suite of innovative electronic products, such as ScienceDirect (www.sciencedirect.com) and MD Consult (www.mdconsult) bibliographic databases, online reference works and subject specific portals. |
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