Mini-Sentinel Safety Review Of Xarelto Expands FDA’s Scrutiny Of Anticoagulants
This article was originally published in The Pink Sheet Daily
The postmarket safety assessment of J&J/Bayer’s Xarelto will use Mini-Sentinel’s Prospective Routine Observational Monitoring Programming Tools surveillance system, a new program that can track new drugs as they enter the market on an ongoing, semi-automated basis.
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FDA’s Janet Woodcock said the agency has not been able to overcome budgetary restrictions that hamper previously discussed plans to develop the Sentinel postmarket drug safety surveillance system into a much broader national resource.
A 2012 Sentinel study didn’t find any problems, but FDA wants a closer look now that the dataset has grown.
The oral anticoagulant generated just $12 million in sales in its first full quarter since it launched in the U.S., lower than expected. Bristol will increase investment in the brand to drive growth.