Non-Hodgkin Lymphoma

FDA accepts Onco TCS new drug application

Published in Medical Letter on the CDC and FDA, June 27th, 2004

Enzon Pharmaceuticals, Inc., (ENZN) and Inex Pharmaceuticals Corporation (INEX, IEX) announced that the new drug application (NDA) for Onco TCS (vincristine sulfate liposomes injection) has been accepted by the U.S. Food and Drug Administration (FDA) and has been granted a Standard Review designation.

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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Source: Medical Letter on the CDC and FDA (2004-06-27)

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