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FDA Announces Changes to Risk Strategy Requirements for Two Drugs to Treat Low Platelet Counts

Posted 7 Dec 2011 by

Includes labeling revisions for both drugs The approval of changes to the Risk Evaluation and Mitigation Strategies (REMS) for both Nplate (romiplostim) and Promacta (eltrombopag) was announced by the U.S. Food and Drug Administration. An FDA-initiated review of the current information has determined that while safety risks for both Nplate and Promacta still exist, certain restrictive ...

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