SuperGen, Inc., has withdrawn its New Drug Application (NDA) for rubitecan (Orathecin™) capsules based on feedback that its data package was insufficient to gain the FDA’s approval at the time. However, the drug’s European filing remains on track, and plans for a U.S. nonrandomized portion of the phase 3 trial of rubitecan plus gemcitabine (Gemzar®, Eli Lilly) as a combination therapy continue to move forward.
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