Sicor Inc announced that the Food and Drug Administration (FDA) has issued a tentative approval of an Abbreviated New Drug Application (ANDA) submitted by its wholly owned subsidiary, Gensia Sicor Pharmaceuticals Inc, for fludarabine phosphate for injection. Fludarabine is indicated for the treatment of patients with B-cell chronic lymphocytic leukemia. Gensia Sicor Pharmaceuticals will utilize active pharmaceutical ingredients (API) manufactured by Sicor's Italian subsidiary, Sicor S.p.A.

Based on data from IMS Health, a market research firm, U.S. sales of fludarabine phosphate for injection in 2002 were approximately $67 million. The branded product, Fludara, is marketed by Berlex Laboratories. Final approval is subject to the resolution of Berlex's application for pediatric exclusivity, which is currently under review at the FDA.