1. Pink Sheet

Par Pursuing Settlement Of FDA Suit And DoJ Off-Label Investigation

 
• By Brenda Sandburg

Parties have stayed their litigation as they continue to hammer out a potential global resolution that would also settle DoJ’s investigation of Megace sales and marketing practices.

The outcome of Par Pharmaceutical Inc.’s suit challenging FDA’s off-label promotion regulations is tied to the government’s investigation of its sales and marketing practices for the AIDS wasting drug Megace ES (megestrol acetate).

Par and FDA stayed the complaint in May as they worked on a global resolution of pending investigations and litigations

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