U.S. rejects Glaxo's gepirone ER antidepressant

U.S. regulators have rejected GlaxoSmithKline Plc's (GSK.L: Quote, Profile, Research) experimental drug gepirone ER for adults with major depression.

The U.S. Food and Drug Administration (FDA) issued a not approvable letter for the extended-release tablets, which Glaxo had licensed from privately owned Fabre-Kramer Pharmaceuticals Inc in February, Europe's biggest drugmaker said on Saturday.

The news is a blow to Glaxo, which needs new drugs to make up for pending patent expiries on key blockbusters and a recent slump in sales of its second-biggest seller, the diabetes pill Avandia, which has been hit by fears over a possible link to heart attacks.

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