FDA re­jects Ab­b­Vie's in­fu­sion ther­a­py for Parkin­son's, re­quests more in­fo on pump de­vice

The FDA re­ject­ed Ab­b­Vie’s 24-hour in­fu­sion ther­a­py for Parkin­son’s, say­ing it needs more in­for­ma­tion on a de­vice used to ad­min­is­ter the treat­ment be­fore it can clear it.

The Chica­go-area drug­mak­er said in a press re­lease that the com­plete re­sponse let­ter from the agency didn’t in­clude any re­quests for more ef­fi­ca­cy or safe­ty tri­als re­lat­ed to the drug, known as AB­BV-951. The com­pa­ny said it aims to “re­sub­mit the NDA as soon as pos­si­ble.”

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