Par Planning Megace ES Launch In Summer 2005 With In-House Sales Force
This article was originally published in The Pink Sheet Daily
Executive Summary
Par is looking for a second product to detail with the 50-60 person force it is building for extra strength Megace. The company hopes to get an "approvable" letter for the product in April and begin detailing in July.
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Par Expects Megace ES Label To Reflect Dosing, Bioavailability Advantages
The company is in discussions with FDA on labeling for the new formulation of megestrol oral suspension. The product’s user fee date was extended by three months to July 29 following FDA’s request, and Par’s submission, of supplemental data supporting the 505(b)(2) NDA.
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