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Gepirone Under Review for Major Depressive Disorder

Published: January 27, 2023

In March 2016 Fabre-Kramer successfully appealed to the Formal Dispute Resolution process to overturn a deficiency impeding approval.

Source: psychiatryadvisor.com

Related Topics:

Stephen KramerJohn JenkinsOffice Of New DrugsDrug AdministrationFabre Kramer PharmaceuticalsNew Drug ApplicationKramer PharmaceuticalsInformal Dispute ResolutionNew DrugsComplete Response ClassPrescription Drug User Fee Act

Fabre-Kramer Pharmaceuticals Announces FDA Acceptance of NDA Resubmission as Complete Response and Assignment of PDUFA Regulatory Action Date

Published: January 24, 2023

/PRNewswire/ -- Fabre-Kramer Pharmaceuticals, a leading developer of novel small molecule medications to address unmet needs in the treatment of psychiatric...

Source: prnewswire.com

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United StatesStephen KramerPrnewswire Fabre Kramer PharmaceuticalsFabre Kramer Pharmaceuticals IncMajor Depressive DisorderKramer PharmaceuticalsComplete Response ClassFabre Kramer Pharmaceuticals