Thursday, March 10, 2016

The FDA Settles With Amarin: Precursor To An Actual Policy On Off-Label Information?

As reported this week, the small pharmaceutical company Amarin has agreed to settle its litigation against the U.S. Food & Drug Administration. Under the terms of the settlement, which is likely to be blessed by U.S. District Court Judge Paul Engelmayer, Amarin may freely promote its product Vascepa (icosapent ethyl) for uses not approved by the FDA so long as the information conveyed to physicians is truthful and not misleading, and the agency also will allow Amarin to use an optional pre-clearance process for new indications through the year 2020.

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