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In Brief: Sepracor levalbuterol

Executive Summary

Sepracor levalbuterol: NDA submitted July 1 for levalbuterol HCl inhalation solution. NDA includes studies in 502 asthma patients. Pivotal four-week, 362-patient Phase III study shows greater improvement in lung function compared with racemic albuterol after the first dose, company says. Single-dose study in children aged three to 11 included in submission. Sepracor is beginning studies of syrup, tablet, metered-dose and dry-powder inhaler...
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PS030476

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