Janssen announces launch of generic Risperdal

Janssen, a division of Ortho-McNeil-Janssen Pharmaceuticals, has announced the launch of a generic version of Risperdal (risperdone) through its subsidiary Patriot Pharmaceuticals.

The company also announced plans to continue to make the branded version of Risperdal available to customers.

Risperdal is indicated as a treatment for schizophrenia in adults and adolescents aged 13-17 years old and is also iniicated as a treatment for irritability associated with autistic disorder in children and adolescents aged up to 16-years old.

The compound is also used as a short-term treatment of bipolar mania in acute or manic mixed episodes as a monotherapy or combination therapy with lithium or valporate in adult bipolar I disorder patients, or as a monotherapy in children and adolescents.

Risperdal was first approved by the US Food and Drug Administration in 1993.

In April 2007, Janssen announced the availability of a new formulation of Risperdal Consta produced by Alkermes and marketed by Jansenn to customise treatment of schizophrenia in patients with other conditions, such as renal and hepatic impairment.

The 12.5mg dose is the smallest available measure of the compound and the approval of its formulation was based on pharmacokinetic rather than clinical data.