Canadian drug maker Biovail Corp. said Thursday it is suing the U.S. Food and Drug Administration to try to stop the agency from approving generic versions of its extended-release antidepressant without addressing issues brought up in a citizen petition.
Biovail is requesting a temporary restraining order and a preliminary injunction against the FDA in the U.S. District Court for the District of Columbia. The actions aim to make the FDA resolve issues raised in the company's Citizen Petition, filed with the FDA Dec. 20, at least one week before the agency approves a generic version of Wellbutrin XL.
The petition lists conditions for ensuring that a generic form of Wellbutrin XL acts the same in the body as the branded drug.
In 2005, Biovail booked Wellbutrin XL sales of $317.3 million, about 36 percent of its total revenue.
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