Mihael Polymeropoulos, Vanda Pharmaceuticals CEO

Phar­ma com­pa­ny con­tin­ues its FDA law­suit spree, this time af­ter agency de­nies fast-track des­ig­na­tion

Van­da Phar­ma­ceu­ti­cals is mak­ing a name for it­self, at least in terms of su­ing the FDA.

The DC-head­quar­tered firm on Mon­day filed its lat­est suit against the agency, with the com­pa­ny rais­ing con­cerns over the FDA’s fail­ure to grant a fast track des­ig­na­tion for Van­da’s po­ten­tial chron­ic di­ges­tive dis­or­der drug tradip­i­tant, which is a neu­rokinin 1 re­cep­tor an­tag­o­nist.

Specif­i­cal­ly, Van­da said FDA’s “es­sen­tial point” in its one-page de­nial let­ter on the des­ig­na­tion point­ed to “the lack of nec­es­sary safe­ty da­ta,” which was “in­con­sis­tent with the cri­te­ria for … Fast Track des­ig­na­tion.”

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