Eisai is fighting the FDA and the DEA for both BELVIQ and FYCOMPA
Suggest going to fdalawblog website and scroll down to August 11, 2013
August 11, 2013
Eisai Says FDA Erroneously Triggered NCE Exclusivity Start Dates Before DEA Controlled Substance Scheduling Permitted Marketing
By Kurt R. Karst
Epilepsy Drug Still Not Available to Patients 10 Months After FDA Approval
WOODCLIFF LAKE, N.J., Aug. 19, 2013 /PRNewswire/ -- Eisai Inc. filed a petition today with the U.S. Court of Appeals for the District of Columbia asking the court to direct the Drug Enforcement Administration (DEA) to promptly schedule the company's epilepsy drug so that it can make it available to patients.
From PR Eisai
Its clear there are serious problems between the DEA and Easai! Both drugs following the same long-winded process. I hope Easai really legally smacks-down the DEA because underlying all this political stuff are patients who obviously were delayed from using both drugs--over some agency/pharma food fight.
Sentiment: Strong Buy