US FDA unease over two drugs

09 August 1997 00:00  [Source: ICB]

Potential top-selling drugs for Roche and Novartis have been held up following US Food and Drug Administration (FDA) concerns over side-effects. Roche will resubmit its weight-loss drug Xenical while Novartis is to reformulate its laxative Ex-Lax.

Shares in Roche fell 5% after the Swiss company failed to respond in time to an FDA request for information on diet drugs which have been linked to breast cancer. Xenical is the first of a new kind of diet drugs called fat blockers that prevent the absorption of fat and could be worth up to an annual $1bn in the $30bn/year US weight-loss market.

A Roche spokesman said Xenical is already partially available and the FDA application will be resubmitted in the next few months. He said: 'We strongly believe there is no association between Xenical and breast cancer.'

Novartis will adapt Ex-Lax, the leading laxative in the $360m/year US market, following the FDA's ultimatum to manufacturers using phenolphthalein in their products to prove the ingredient is not responsible for tumours. It will now contain senna instead.

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