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Biotech / Medical : CLTR COULTER PHARMACEUTICAL
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To: Biomaven who wrote (640)11/1/2000 5:14:31 PM
From: keokalani'nui  Read Replies (1) of 666
 
What a shame a year was lost.

Wednesday November 1, 5:00 pm Eastern Time
Press Release
IDEC Pharmaceuticals Submits Biologics License Application for ZEVALIN Radioimmunotherapy to the U.S. Food and Drug Administration
SAN DIEGO--(BW HealthWire)--Nov. 1, 2000--IDEC Pharmaceuticals Corporation (Nasdaq:IDPH - news) today announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) seeking marketing approval of ZEVALIN(TM) (Ibritumomab Tiuxetan). This radioimmunotherapy is proposed for the treatment of low grade or follicular, relapsed or refractory, CD20-positive, B-cell non-Hodgkin's lymphoma (NHL) and Rituximab-refractory follicular NHL, which is cancer of the lymphatic system.

IDEC also noted the FDA had designated ZEVALIN a Fast Track Product for the treatment of relapsed or refractory, low grade or follicular NHL. Under the FDA Modernization Act of 1997, designation as a Fast Track Product means that the FDA will facilitate the development and expedite the review of a drug if it is intended for the treatment of a serious or life-threatening condition, and it demonstrates the potential to address unmet medical needs for such a condition.

Acceptance for review of the license application by the FDA will be determined within 60 days of submission. >>snip<<
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