Thursday, August 30, 2012

Reuters: Regulatory News: UPDATE 1-US FDA approves Ironwood constipation drug

Reuters: Regulatory News
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UPDATE 1-US FDA approves Ironwood constipation drug
Aug 30th 2012, 15:20

Thu Aug 30, 2012 11:20am EDT

Aug 30 (Reuters) - The U.S. Food and Drug Administration on Thursday approved Ironwood Pharmaceuticals Inc's drug to treat chronic constipation and irritable bowel syndrome with constipation in adults.

The drug, linaclotide, will be sold under the brand name Linzess and carry a boxed warning that the drug should not be used in patients 16 years of age or younger, the agency said.

"No one medication works for all patients suffering from these gastrointestinal disorders," Victoria Kusiak, a deputy director at the FDA's Center or Drug Evaluation and Research, said in a statement. "With the availability of new therapies, patients and their doctors can select the most appropriate treatment for their condition."

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