Published in Medical Letter on the CDC and FDA, June 27th, 2004
Based on this designation, the FDA has established a target date of January 15, 2005, for completion of review of the Onco TCS NDA.
The NDA is seeking marketing approval for Onco TCS as a single-agent treatment for patients with relapsed aggressive non-Hodgkin lymphoma (NHL) previously treated with at least two combination chemotherapy regimens.
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