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Spiriva Receives Recommendation for Approval by FDA Advisory Committee

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Friday September 6, 5:56 pm ET

RIDGEFIELD, Conn., Sept. 6 /PRNewswire/ -- Boehringer Ingelheim Pharmaceuticals, Inc. said today that an Advisory Committee to the U.S. Food and Drug Administration recommended approval of SPIRIVAź (tiotropium bromide inhalation powder) for the long-term, once-daily maintenance treatment of bronchospasm associated with Chronic Obstructive Pulmonary Disease (COPD).

SPIRIVA, a novel once-daily inhaled anticholinergic treatment that works through prolonged M-3 receptor blockade, was discovered and developed by Boehringer Ingelheim.

Boehringer Ingelheim and Pfizer Inc have agreed to co-promote SPIRIVA worldwide.

The application Boehringer Ingelheim filed with the FDA included data from six clinical trials including more than 2,600 patients. The most common adverse reaction reported in SPIRIVA patients in these trials was dry mouth that was usually mild and often resolved during treatment.

Source: Boehringer Ingelheim Pharmaceuticals, Inc.

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