Advisory Committee Votes

Is the reintroduction of tegaserod to the US market supported by the available safety data?

Y - 11, N - 1

Do you agree that the therapeutic gain (treatment difference between tegaserod and placebo patients) is generally similar in magnitude between the severely symptomatic and originally approved population?

Y - 12, N - 0

In which patient population would you expect the benefits to outweigh the risks for patients treated with tegaserod?

IBS-C females - 1

IBS-C females at low CV risk - 7

IBS-C females who are severely symptomatic - 0

IBS-C females at low CV risk and who are severely symptomatic - 3

Other - 1

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