Sepracor Submits NDA For Levalbuterol

8 July 1997

Sepracor has submitted a New Drug Application to the US Food and DrugAdministration for approval to market levalbuterol HCl inhalation solution, a single-isomer formulation of racemic albuterol, for the treatment of asthma.

The NDA comprises data from nine studies involving 502 asthmatics and 42 healthy volunteers. In one four-week, 362-patient study, levalbuterol was shown to have a greater improvement in lung function than racemic albuterol after the first dose. Over the study period, levalbuterol (1.25mg and 0.625mg) had equivalent or greater changes in forced expiratory volume, compared with 2.5mg of albuterol.

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