| Company (Symbol) | Product | Description | Indication | Action (Date) |
| Centocor Inc. (subsidiary of Johnson & Johnson; NYSE:JNJ) | Remicade (FDAapproved) | Infliximab; chimeric monoclonal antibody to tumor necrosis factoralpha | Prevention of joint damage in patients with rheumatoid arthritis | Priority review status granted (1/27); FDA s Arthritis Advisory Committee voted unanimously to recommend approval (7/12) |
| Millennium Pharmaceuticals Inc. (MLNM) and Ilex Partners LP (joint venture of Millennium and Ilex Oncology Inc.; ILXO) | Campath | Alemtuzumab; humanized monoclonal antibody | Chronic lymphocytic leukemia | Received a complete response letter for BLA delineating deficiencies (6/26); ILEX responded to BLA letter (8/21); The Oncologic Advisory Committee voted 14-to-1 to recommend accelerated approval of Campath (12/15) |
| Palatin Technologies Inc. (AMEX:PTN) and Mallinckrodt Inc. (NYSE:MKG) | LeuTech | Radiolabeled monoclonal antibody-based system for imaging infection | Diagnosis of equivocal appendicitis | BLA accepted for review (2/23); FDA scheduled advisory panel meeting for 7/10 (6/5); FDA s Medical Imaging Drugs Advisory Committee voted 8-0 to recommend the product for approval (7/10); FDA requested additional manufacturing and process-validation data for the BLA (9/28) |
