Eisai to sue DEA over Fycompa scheduling delay

Eisai’s epilepsy medication, Fycompa, was approved by the FDA in October of last year, however, the company is still waiting for the US Drug Enforcement Administration (DEA) to classify the drug as a controlled substance, delaying the treatment from coming to market. Eisai has now begun legal action against the DEA.

The Japanese pharmaceutical company has called the delay “unreasonable and egregious” and has asked for intervention from the U.S. appeals court in the District of Columbia.

 

The FDA sent its scheduling recommendation for Fycompa to the DEA in January 2013, but seven months later the DEA has not yet begun the scheduling process.
 
Eisai’s US subsidiary in a statement.

The average time for the DEA to classify drugs has increased 49 to 238 days since the late 1990’s.

Related news:

Fed up with Fycompa delay, Eisai slaps DEA with lawsuit (Fierce Pharma)

Japan’s Eisai Sues DEA, Seeking Clearance of Epilepsy Drug (The Wall Street Journal)

Eisai sues DEA over Fycompa scheduling (PM Live)

Drug company Eisai sues DEA to expedite drug ‘scheduling’ (Digital Journal)

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