The two companies filed a New Drug Application on Jan. 9, 2009 and learned in November that the agency extended the review date of Horizant to Feb. 9 to perform a risk evaluation and mitigation plan for the drug.

FORBES: FDA Concerns Shake XenoPort, DepoMed

But Sabril needed a Risk Evaluation and Mitigation System (REMS), FDA jargon for a plan that ensures drugs are only used when benefits outweigh risks.

FORBES: Magazine Article