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Risperdal approval, "complete response" & revised warnings

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Janssen Risperdal M-Tab launch begins during second week of May, following FDA approval of the fast-dissolving formulation of risperidone April 2. The company claims that the orally disintegrating tablets will boost compliance. Janssen began an advertising campaign stressing compliance in the fall. Janssen also is highlighting a compliance benefit for its sustained-release formulation of the atypical antipsychotic, Risperdal Consta. The firm filed a "complete response" for Risperdal Consta April 28, suggesting an October user fee goal. The product was deemed "not approvable" due to preclinical toxicology issues June 28, 2002. Janssen sent a "Dear Healthcare Provider" letter April 16 on updated safety labeling for Risperdal. A new warning on the risk of stroke notes cerebrovascular adverse events in risperidone trials of elderly patients with dementia-related psychosi

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