FDA issues gepirone ER not approvable letter

Fabre Kramer (Houston, Texas) and GlaxoSmithKline (LSE:GSK; GSK) said FDA issued a not approvable letter for an NDA for gepirone extended-release tablets to treat adults with major depressive disorder. A 2004 not approvable letter for the serotonin (5-HT1A) receptor agonist requested an additional short-term efficacy trial, the results for which were submitted in May. The partners said the new not approvable letter was based on FDA's review of those results along with other newly submitted and previously submitted data. Further details were not disclosed. ...