Skip to content

Depomed, Orphan Drug Gralise (Gabapentin), And The FDA: What Is Going On ?

September 26, 2012

       What is going on between Depomed, orphan drug Gralise (Gabapentin), and the FDA ?

       Depomed announces on September 25, 2012, that it has filed a lawsuit in federal district court for the District of Columbia against the FDA, “seeking an order requiring the FDA to grant Gralise Orphan Drug exclusivity for the management of postherpetic neuralgia or PHN”.

       Here are the facts about Orphan Drug Gralise :

–     Receives FDA Orphan Drug Designation (ODD) November 8, 2010 for the management of PHN

–     Receives FDA orphan approval for PHN on January 28, 2011

–     FDA has not granted “orphan drug exclusivity” to Gralise, even though the product is approved for its orphan designated use.

         Depomed believes Gralise is entitled to Orphan Drug exclusivity as a “matter of law, and the FDA’s action is not consistent with the statute or FDA’s regulations related to orphan drugs”. The lawsuit is asking the court to determine that Gralise is protected by Orphan Drug exclusivity, and a court order that FDA acts accordingly.  

References September 25, 2012 Article titled,”Depomed sues FDA to get orphan drug status for Gralise to treat shingles complications” September 25, 2012 Article titled, “Depomed files suit against FDA seeking grant of Orphan Drug Exclusivity for Gralise”

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

Leave a Comment

Leave a Reply

Fill in your details below or click an icon to log in: Logo

You are commenting using your account. Log Out / Change )

Twitter picture

You are commenting using your Twitter account. Log Out / Change )

Facebook photo

You are commenting using your Facebook account. Log Out / Change )

Google+ photo

You are commenting using your Google+ account. Log Out / Change )

Connecting to %s

%d bloggers like this: