Novartis ordered to pull advert for breast cancer drug
The United States health authorities have ordered the Swiss healthcare giant, Novartis, to pull an advertisement from a medical journal because it fails to conform to advertising regulations.
In a letter to Novartis, the US Food and Drug Administration (FDA) said an advertisement for the recently approved hormone drug, "Femara", claimed the medication could treat illnesses for which it was not certified.
It said the advertisement, which appeared in the medical journal, "Oncology", failed to explain clearly the treatment for which "Femara" had been certified and that it did not contain the required information about side-effects.
It said this information had also been repeated in a press release of January 11 (web address below).
The FDA said Novartis had claimed that Femara was a pre-operative treatment for reducing the size of chest tumours. However, the drug has been certified only for first-line treatment for advanced breast cancer in post-menopausal women.
Femara was given the green light in the US last month, following a fast-track review by the US food and drug administration. It has since been approved in Europe.
Novartis would only say that it was preparing its response.
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