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Article: M&I Partners' Response Concerning CAMPATH Accepted by FDA.
- Article from:
- Business Wire
- Article date:
- April 6, 2001
CopyrightCOPYRIGHT 2001 Business Wire. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan. All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)
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Business Editors & Health/Medical Writers
SAN ANTONIO--(BUSINESS WIRE)--April 6, 2001
ILEX(tm) Oncology Inc. (Nasdaq:ILXO) today announced the receipt of a letter from the U.S. Food and Drug Administration (FDA) to Millennium & ILEX Partners, L.P. (M&I Partners) stating that the agency intends to take action by May 19, 2001 on the partnership's Biologics License Application (BLA) for CAMPATH(R) (alemtuzumab).
In its letter, the FDA stated that it accepted the partnership's response to the agency's Feb. 20, 2001 action letter on March 19, 2001, and considers it "a complete, Class 1 response." The letter further stated that the FDA's Center for ...