Cancer Research

U.S. FDA requests additional data to establish bioequivalence between LEP-ETU and Taxol

Published in Medical Letter on the CDC and FDA, March 12th, 2006

The U.S. Food & Drug Administration (FDA) has now advised NeoPharm, Inc. that additional data is required to establish bioequivalence between Liposomal Paclitaxel "Easy to Use" (LEP-ETU) and Taxol prior to beginning a clinical efficacy trial. NeoPharm plans to begin a 100 patient clinical efficacy trial of LEP-ETU before it submits a 505(b)(2) new drug application (NDA) for marketing approval.

The company is preparing to submit the additional requested data in advance of a meeting with the FDA scheduled for the second quarter of this year. As a result, initiation of the proposed clinical efficacy trial of LEP-ETU would commence, at the earliest, in the second quarter...

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Source: Medical Letter on the CDC and FDA (2006-03-12)

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