Risperdal M-Tab is indicated for the treatment of schizophrenia, and the short-term treatment of acute manic or mixed episodes associated with bipolar disorder. The drug is made by Janssen Pharmaceutica, a unit of J&J.
The product had annual sales of approximately $67 million for the twelve months ended August 2005, based on IMS sales data.
Barr filed its abbreviated new drug application for risperidone orally disintegrating tablets to the FDA in March 2005 and received notification of the application’s acceptance for filing in August 2005.
On October 3, 2005, Janssen filed a suit in the US District Court of New Jersey to prevent Barr from proceeding with the commercialization of the product.