Savient Pharmaceuticals, Inc. has received approval from the US FDA for its pre-market approval application (PMA) for Nuflexxa (1% Sodium Hyaluronate).

Nuflexxa is indicated for the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy and simple analgesics (e.g., acetaminophen). The product is also approved in Europe where it will be marketed under the brand name Euflexxa.

Nuflexxa is the first and only non-avian derived HA approved in the US. It is a product of Bio-Technology General (Israel) Ltd., Savient's wholly owned subsidiary.

Savient is in the process of completing a supplement to the labelling to support room temperature storage versus the refrigerated expiration dating approved by the FDA. The supplement is expected to be submitted early in the first quarter of 2005.

The Company is in late-stage negotiations with a global marketing partner for both Nuflexxa in the United States and Euflexxa in Europe. These negotiations are expected to conclude early in 2005, the company release said.

"We are pleased to have reached this milestone in the development of Nuflexxa. We believe its commercialization in 2005 represents additional value to our previously announced potential divestiture of our subsidiary Bio-Technology General (Israel) Ltd.," said Christopher G. Clement, president and CEO of Savient Pharmaceuticals, Inc.