FDA Ruling On Gepirone Efficacy Data Delayed By One Month

Fabre-Kramer responds to Office of New Drugs Director Jenkins' invitation to submit additional information following advisory committee review; Jenkins' decision on the antidepressant now expected by end of January.

Fabre-Kramer Pharmaceuticals Inc.'s years-long bid to bring the antidepressant Travivo (gepirone extended-release) to the US market has hit another regulatory delay as FDA considers additional arguments in the company's dispute resolution request.

Office of New Drugs Director John Jenkins is now expected to rule on the company's appeal over the adequacy of...

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