Maxim Pharmaceuticals Inc. is looking for a life preserver. The San Diego company conceded that another Phase III trial of Ceplene (histamine dihydrochloride) is needed before it seeks FDA approval of the product. The decision was based on ongoing correspondence with the agency, as well as consultations with external advisers, both of which determined that the additional study of Ceplene combined with interleukin-2 for acute myeloid leukemia patients in complete remission would be necessary before applying for marketing clearance in the U.S. (BioWorld Today)
Maxim Pharmaceuticals Inc. is looking for a life preserver. The San Diego company conceded that another Phase III trial of Ceplene (histamine dihydrochloride) is needed before it seeks FDA approval of the product. The decision was based on ongoing correspondence with the agency, as well as consultations with external advisers, both of which determined that the additional study of Ceplene combined with interleukin-2 for acute myeloid leukemia patients in complete remission would be necessary before applying for marketing clearance in the U.S. (BioWorld Today)
