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FDA Rejects New Drug for Irritable Bowel Syndrome

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In addition, the FDA issued an "approvable" letter to Novartis in August, which stated that the drug could be approved, provided the company conducted one additional trial to confirm that the drug was safe and effective. Novartis conducted this trial and thought it had satisfied the FDA's concerns, Pozarek says.

"It is unusual" for the FDA not to follow the recommendation of its advisory committees, which consist of independent experts, Brodsky says, but he declined to offer further insight on why the FDA rejected Zelnorm.

Pozarek says Novartis has not decided if it will appeal the FDA's decision.

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