Anger over FDA 'brake on Glaxo'

The strategy of GlaxoSmithKline to extend sales of its biggest-selling drugs is under threat from the US Food and Drug Administration, critics of the agency say.

The FDA is accused of posing new questions to Glaxo as it re-submits previously approved drugs.

Nomura analyst Mike Ward, said: "The whole industry is finding it difficult because the FDA is understaffed, and focusing on things they think are more innovative and important."

The agency approved Glaxo's Parkinson's disease treatment Requip XL, a modified version of the older drug Requip, at the weekend. But delays mean a generic version is already on the market.

Christopher Viehbacher, president of North American pharmaceuticals for Glaxo, said it is harder to get approval for variations of drugs because the FDA now demands to know why they are better than the original.