Lev Pharmaceuticals Inc.

Lev Pharmaceuticals Inc. announced that it has been advised that the Blood Products Advisory Committee (BPAC) for U.S. Food and Drug Administration (FDA) intends to review the Biologics License Application (BLA) for Cinryze (C1 inhibitor) on May 2, 2008, for the prophylactic treatment of hereditary angioedema (HAE), or C1 inhibitor deficiency. Advisory committees provide FDA with independent advice from outside experts. The BPAC meeting represents the next stage in the regulatory process for Lev as the Company continues to work with FDA toward obtaining market approval for Cinryze. Lev received a complete response letter from FDA on January 30, 2008, which requested information with respect to chemistry, manufacturing, and controls (CMC), as well as additional analyses of existing efficacy data from the Cinryze trials.Additionally, Cinryze has been well tolerated with an adverse event profile no different from placebo. The most common adverse reactions observed have been injection site rash and lightheadedness. No drug-related serious adverse events (SAEs), no immunogenicity and no decrease in efficacy have been observed. C1 inhibitor has been used for more than 35 years in Europe to treat patients with C1 inhibitor deficiency.