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Acquittals FDA Approval

King & Spalding

Amarin and FDA Reach Settlement Agreement in Off-Label Speech/First Amendment Case

King & Spalding on

On March 8, 2016, Amarin Pharmaceuticals, Inc. (“Amarin”) and the Food and Drug Administration (“FDA” or the “Agency”) reached a settlement agreement in a closely followed case involving Amarin’s First Amendment rights to...more

Skadden, Arps, Slate, Meagher & Flom LLP

"One-Two Punch: Amarin Settlement Order and Vascular Solutions Acquittal Further Erode Off-Label Promotion Enforcement Regime"

In an apparent first, the U.S. Food and Drug Administration (FDA) has conceded that a pharmaceutical company may engage in truthful and nonmisleading speech promoting the off-label use of a prescription drug. This concession...more

King & Spalding

K&S Effort Leads to Acquittal in Conspiracy and Misbranding Case Against Medical Device Company

King & Spalding on

On February 29, 2016, Minneapolis-based medical device company Vascular Solutions, Inc. (“VSI”) and its CEO Howard Root were acquitted by a jury of conspiracy and misbranding charges in a closely-followed trial in San...more

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