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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
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And the only real answer is reallocating money from the federal flood-insurance program and other flood-mitigation projects to this plan.
NPR: Feds Propose Massive Buyout for Mississippi Coast
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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