American Pharmaceutical Partners (APP) has received 180 days of marketing exclusivity and approval from the U.S. Food and Drug Administration (FDA) for the Abbreviated New Drug Application (ANDA) of calcitriol injection. Calcitriol, the generic equivalent of Abbott Laboratories Inc's Calcijex, is indicated in the management of hypocalcemia in patients undergoing chronic renal dialysis. According to IMS, in 2001, U.S. sales of calcitriol and similar products for the treatment of hypocalcemia exceeded $250 million. The 180 day exclusivity period will commence upon APP's launch of this product, which is anticipated to be by mid 2003.

"I am pleased to report that our first approval of 2003 continues our company's impressive track record for product development and approvals," said Patrick Soon-Shiong, chairman, president and chief executive officer. "Together with the 12 approvals received in 2002, and the four in the month of December alone, APP is well positioned to continue its high growth in the injectable pharmaceutical sector. Calcitriol along with APP's broad critical care portfolio, enhances our ability to further penetrate the alternate care site and hospital based markets."