Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By


Third Strike For Gepirone ER: Fabre-Kramer/GSK Antidepressant “Not Approvable” Again

This article was originally published in The Pink Sheet Daily

Executive Summary

Antidepressant received two FDA “not approvable” letters when it was licensed to Organon.

You may also be interested in...

Do Negative Trials Count More Than Successful Ones?

Fabre-Kramer, FDA dispute over efficacy of the antidepressant gepirone heads to Psychopharmacologic Drugs Advisory Committee.

Is Fabre-Kramer’s Gepirone Antidepressant Rising From The Dead After 8 Years?

Nothing has been heard about the major depressive disorder treatment since FDA issued a third “not approvable” letter in 2007; advisory committee to discuss NDA in December.

Fabre-Kramer/GSK Submit Gepirone ER For Major Depressive Disorder

Firms are seeking to secure FDA approval of the first-in-class 5HT1a agonist with new data.

Related Content


Latest Headlines
See All



Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts