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FDA Revokes Orphan Drug Exclusivity For Octapharma’s Wilate (September 28, 2012 Update)

September 27, 2012

       This is an update to the Orphan Druganaut September 5, 2012, Blog Post.

       A law firm, Arnall Golden Grepory LLP, wrote a “Client Alert” titled, “FDA Leaves an Orphan Out in the Cold”. On August 8, 2012, the FDA rescinds the 7-year orphan drug marketing exclusivity for Octapharma’s Wilate for the treatment of Von Willebrand Disease (VWD). The FDA response document says it made a mistake when granting orphan drug exclusivity on December 4, 2009 to orphan drug Wilate. The FDA says there is a strong difference between “orphan drug exclusivity”, which it took away, and “orphan drug designation”, which Wilate continues to have.

       The law firm’s “Client Alert” highlights what they consider are important FDA points and issues, which orphan drug companies should consider for orphan drug development. The “Client Alert” notes “how, nearly 30 years since the passage of the Orphan Drug Act, the agency’s views continue to emerge”.

       Is Octapharma’s lawsuit similar to Depomed’s recent filing of a lawsuit (Orphan Druganaut September 26, 2012 Blog Post) against the FDA, on September 25, 2012 ?

       Depomed is “seeking an order requiring the FDA to grant Gralise orphan drug exclusivity for the management of PHN”.  In this situation, orphan drug Gralise has “orphan drug designation” but doesn’t have “orphan drug exclusivity”.

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

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