its efforts to keep Biogen Inc.'s competing multiple sclerosis drug offthe market. But Berlex may have lost much more than that _ it'sincurred the wrath of the very individuals who are ultimately theconsumers of its own multiple sclerosis drug, Betaseron.
The FDA has licensed Biogen's drug Avonex; it gave the final seal ofapproval on May 17, 1996, and Biogen, of Cambridge, Mass., startedselling the drug on May 20, 1996. The issues that surround the suitbrought by Berlex, however, remain unresolved.
In Monday's issue of BioWorld Financial Watch, Editor Jennifer VanBrunt explains the suit, how Berlex has questioned the FDA'sprocedures and the orphan drug law. The company has raised anumber of complex issues that it still intends to be heard by a judgein the U.S. District Court of the District of Columbia.
This is not the first time that a company has sued the FDA, but it'snot a common occurrence. Read about it in BioWorld FinancialWatch. Call (800) 879-8790 for a copy. n
-- being denied a restraining order to prevent the FDA from approving
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