Fabre-Kramer and GSK get "not approvable" for gepirone ER

Houston, USA-based Fabre-Kramer Pharmaceuticals and UK drug major GlaxoSmithKline have been issued with a "not approvable" letter by the Food and Drug Administration regarding the co-developed major depressive disorder drug, gepirone ER. The decision, which follows the submission of additional supporting data earlier this year (Marketletter May 14), is a setback for both companies, but particularly for GSK which had hoped that, following a series of high profile problems, gepirone would bolster its product range and match analysts' peak sales forecasts of between $800.0 million and $1.6 billion.