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Ascent Pediatrics Primsol trimethoprim solution launch expected in 1997 -- company IPO.

Executive Summary

ASCENT PEDIATRICS PRIMSOL TRIMETHOPRIM SOLUTION LAUNCH PLANNED FOR 1997, the company states in an April 25 initial public offering prospectus. Ascent Pediatrics has an NDA pending for Primsol as an alternative to trimethoprim/ sulfamethoxazole in the treatment of acute otitis media in children. In January, FDA's Anti-Infective Drug Products Division "notified Ascent that it recommended approval of the company's NDA for Primsol solution for the treatment of AOM in children age six months to 12 years, with a label reflecting that Primsol solution would not be a product for first line therapy for this indication," the prospectus states. Based on that communication, "Ascent expects to receive marketing approval from FDA...in the first half of 1997" following completion of labeling discussions.

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