FDA makes it of­fi­cial, once again re­ject­ing bat­tered Cor­re­vio’s heart drug

Thir­teen years af­ter Cor­re­vio first tried — and failed — to gain an ap­proval for the heart drug ver­nakalant, the FDA has hand­ed them their lat­est CRL. It’s like­ly their last.

The agency spurned the lit­tle biotech — once called Car­diome — in the wake of a lop­sided 11-2 vote against mar­ket­ing ap­proval. Sub­ject­ed to a clin­i­cal hold at one stage, the atri­al fib­ril­la­tion drug has been un­der a dark safe­ty cloud.

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