FDA expands approval of Spriva Respimat (tiotropium bromide) inhalation spray for maintenance treatment of asthma in children

Boehringer Ingelheim

16 February 2017 - Supplemental new drug application approved under priority review from the FDA.

Boehringer Ingelheim today announced that the U.S. FDA approved Spiriva Respimat for the long-term, once-daily maintenance treatment of asthma in people age 6 and older. Spiriva Respimat is not a treatment for sudden asthma symptoms.

The FDA approved the Supplemental new drug aapplication under a priority review designation, and the FDA also granted paediatric exclusivity to Spirava Respimat in light of the clinical trials conducted by Boehringer Ingelheim.

Read Boehringer Ingelheim press release

Michael Wonder

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Michael Wonder

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Outcome , Medicine , US , Paediatrics