November 30, 2004
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., Nov. 30 /PRNewswire/ -- 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).
Dec. 1, 2004FDA Oncologic Drugs Advisory Committee Webcast
8:00 a.m. EST
Watch live on Dec. 1 as FDA's Oncological 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 leukemia.
Ilex' Clolar is undergoing priority review by FDA and is indicated for treatment of refractory or relapsed acute lymphocytic leukemia (ALL) and acute myeloid leukemia (AML) 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 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
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
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