Resources for Food and Drug Administration (FDA)
FDA Floors Eli Lilly
www.fool.com Eli Lilly received an especially harsh rebuke from the FDA on Thursday about one of its top candidates. The agency refused to approve a long-lasting injection (LAI) version of the company's multibillion-dollar Zyprexa for schizophrenia and bipolar disorder.
In a surprise move, the Food and Drug Administration issued a non-approvable letter for the injection because of questions about the "excessive sedation events" seen in patients taking the drug. Rather than issue an approvable letter or a narrow label for the drug, the FDA ignored the advice of a somewhat positive advisory panel that had voted in favor of approval.
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