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What Do K-V Pharmaceutical, Depomed, And Octapharma Have In Common ?

September 27, 2012

       What do K-V Pharmaceutical, Depomed, and Octapharma have in common ?

       The 3 companies have been affected by the FDA’s actions concerning “orphan drug designation” and “orphan drug exclusivity” :

1) K-V Pharmaceutical files a lawsuit against the FDA to “restore orphan drug exclusivity” for Makena; K-V Pharmaceutical loses 

2)  FDA’s decision to “rescind” Octapharma’s “orphan drug exclusivity” for Wilate 

3)  Depomed files a complaint this past week questioning why the FDA gave Gralise an “orphan drug designation”, but not “orphan drug exclusivity”.

       The FDA Law Blog’s September 26, 2012 Post titled, “Another Orphan Drug Battle; Depomed Sues FDA Over Gralise Orphan Drug Exclusivity” reviews the “orphan drug designation” and “orphan drug exclusivity” challenge.     

Copyright  © 2012-2013, Ann-Teresa Cusenza and Orphan Druganaut Blog.  All rights reserved.

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