FDA staff raises safety concerns regarding Novartis' everolimus

12/3/2009 | Reuters

FDA reviewers cited safety issues concerning everolimus, Novartis' drug to prevent organ rejection in kidney transplant patients, ahead of review by an advisory panel for the product's approval. Female patients on everolimus "had a higher failure rate and more premature treatment discontinuation" compared with those taking Novartis' Myfortic, agency staff said.

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