Citizen Petition

August 13, 2015 – On August 3, 2015, Provensis Ltd., a specialty healthcare company which manufactures Varithena (a prescription injectable foam used to treat varicose veins), filed a petition requesting the FDA Center for Devices and Radiological Health withdraw the February 20, 2015 premarket approval for the VenaSeal Closure System (“VenaSeal”), a potential non-prescription competitor for Varithena.  Provensis alleges that VenaSeal is a “highly-reactive chemical agent which is activated after injection [and] operates primarily by chemical action within the body.”  As a result, the citizen petition requests that the premarket approval be reconsidered and withdrawn because VenaSeal primarily acts as a drug and must be viewed through the FDA’s New Drug Application process.

By:  Ketan V. Patel

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