Lev submits complete response letter to FDA for Cinryze

NEW YORK In response to the Food and Drug Administrations issuance of a complete response letter, Lev Pharmaceuticals announced that it has formally submitted the form for Cinryze, a treatment used for acute and prophylactic treatment of hereditary angioedema.

According to published reports, the complete response letter issued by the FDA requested more information about the chemistry, manufacturing and controls of the treatment, as well as any additional data from the Cinryze clinical trials.

The focus for Lev is to obtain market approval for the treatment by the FDA and is scheduled to present to the Blood Products Advisory Committee on May 2, 2008, to educate and provide more information about the product.