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Par Expects Megace ES Label To Reflect Dosing, Bioavailability Advantages

This article was originally published in The Pink Sheet Daily

Executive Summary

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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