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# CDER Grants Fabre-Kramer Appeal on Travivo
- URL: https://www.fdaweb.com/cder-grants-fabre-kramer-appeal-on-travivo/
- Published: 2016-03-18T12:00:00.000Z
- Updated: 2026-09-14T20:50:01.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5135136

FDA’s Office of New Drugs (OND) has granted a Fabre-Kramer Pharmaceuticals appeal through the agency’s formal dispute resolution process and has concluded that its Travivo (gepirone) demonstrates substantial evidence of effectiveness in treating major depressive disorder, thereby overturning the agency’s previous position reached at a lower level. According to the company, OND director John Jenkins stated that in reaching his decision, he considered company-submitted materials, its two trials with effect sizes similar to already approved antidepressants, and consultations with staff including CDER Director of the Division of Biostatistics, **Lisa LaVange**. The company says it will meet with CDER’s Division of Psychiatry Products to discuss remaining details prior to resubmitting the NDA.