Sicor Inc announced that the Food and Drug Administration (FDA) has issued final approval of an Abbreviated New Drug Application (ANDA) submitted by its wholly owned subsidiary, Sicor Pharmaceuticals Inc, for fludarabine phosphate for injection. Fludarabine is indicated for the treatment of patients with B-cell chronic lymphocytic leukemia who have not responded to or whose disease has progressed during treatment with at least one standard alkylating-agent containing regimen. Capitalizing on its vertical integration advantage, Sicor Pharmaceuticals will utilize the active pharmaceutical ingredient manufactured by Sicor's Italian subsidiary, Sicor S.p.A. This is the first generic approval for fludarabine.

Based on data from IMS Health, a market research firm, U.S. sales of fludarabine phosphate for injection in 2002 were approximately $70 million. The branded product, Fludara, is marketed by Berlex Laboratories.