Barr Pharmaceuticals Inc. has announced that its subsidiary Pliva has received tentative approval from the US Food and Drug Administration (FDA) for its generic version of Janssen Pharmaceutica Products, L.P.'s Risperdal (Risperidone) tablets, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg and 4 mg.

A tentative approval reflects FDA's determination that a generic product satisfies the requirements for final approval, subject to the expiration of all statutorily imposed non-approval periods. A tentative approval does not allow the applicant to market the generic drug product.

The company's Abbreviated New Drug Application (ANDA) containing a paragraph III certification was filed with the FDA for Janssen's Risperdal (Risperidone) tablets, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg and 4 mg on June 29, 2005. The paediatric exclusivity attached to the patent protecting Risperdal is scheduled to expire on June 29, 2008, and the company anticipates receiving final approval and marketing the product upon the expiration of that exclusivity.

Risperdal is indicated for the treatment of schizophrenia, and the short- term treatment of acute manic or mixed episodes associated with Bipolar I Disorder. The product had annual sales of approximately $2.5 billion for the twelve months ending March 2007, according to IMS sales data.