Eisai's Attacks Pressure Feds To Patch Exclusivity Holes

Law360, New York (August 20, 2013, 9:04 PM ET) -- Eisai Co. Ltd.’s unusual two-pronged attack on federal agencies over regulatory delays that have prevented it from selling two new prescription drugs could help decide whether drugmakers whose products pose risks of abuse can actually take full advantage of their market exclusivity, experts say.

The Japan-based drugmaker appears to be one of the few companies to have publicly challenged the U.S. Food and Drug Administration and U.S. Drug Enforcement Administration over delays in scheduling controlled substances and subsequent impacts on the length of exclusivity.

Eisai has...
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