Sepracor filings
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Firm submits NDA March 9 for Soltara (norastemizole 30 mg capsules) for treatment of allergic rhinitis. Sepracor is also developing a Soltara pseudoephedrine combo product, a syrup and a rapidly dissolving tablet. On March 30, the firm submitted an sNDA for a lower dosage strength of its inhaled drug Xopenex (levalbuterol) for prevention of bronchospasm in children aged 4 to 11. The drug currently is indicated for patients 12 and older. Sepracor plans a fourth quarter filing for the sleep disorders agent (s)-zopicolon