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FDA approves Amitiza label change


WASHINGTON The Food and Drug Administration’s Center for Drug Evaluation and Research has approved a labeling change to Sucampo Pharmaceuticals chronic idiopathic constipation drug Amitiza.

The new label allows for the 8 mcg version of the drug to be taken twice daily for the treatment of irritable bowel syndrome with constipation in women 18 years and older.

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