Van­da inks $11.5M deal to set­tle off-la­bel drug pro­mo­tion ac­cu­sa­tions

Van­da Phar­ma­ceu­ti­cals took the FDA to court three sep­a­rate times this year as it strug­gles to win over reg­u­la­tors with its sleep and chron­ic di­ges­tive dis­or­der drugs. Now, the com­pa­ny has agreed to drop $11.5 mil­lion to set­tle claims that it il­le­gal­ly pro­mot­ed the sleep drug and one oth­er off-la­bel.

A suite of in­vestors filed a class ac­tion suit against Van­da back in 2019, al­leg­ing that the com­pa­ny pro­mot­ed un­ap­proved us­es for its two com­mer­cial drugs Fanapt and Het­lioz, the for­mer of which treats schiz­o­phre­nia in adults and the lat­ter of which is cleared for sleep dis­rup­tions in those with Smith-Ma­ge­nis syn­drome and Non-24, a cir­ca­di­an rhythm dis­or­der com­mon in blind pa­tients.

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