New Drug Approvals: February 2004

Date of Approval: February 4, 2004

Company: Eli Lilly

Treatment for Malignant Pleural Mesothelioma

Alimta is an antifolate antineoplastic agent used in combination with cisplatin for the treatment of malignant pleural mesothelioma in patients who are not candidates for surgery.

Date of Approval: July 24, 2003

Company: Galderma Laboratories

Treatment for Atopic Dermatitis, Psoriasis

Clobex is a Class I steroid in lotion form to help control and treat steroid-responsive dermatoses including moderate-to-severe atopic dermatitis and moderate-to-severe psoriasis.

Date of Approval: February 4, 2004

Company: Anika Therapeutics, Inc.

Treatment for Osteoarthritis

Orthovisc is a highly purified, high molecular weight form of hyaluronic acid used for treating pain in patients suffering from osteoarthritis (OA) of the knee who have failed to respond adequately to conservative non-pharmacologic therapy and to simple analgesics.

Date of Approval: February 9, 2004

Company: Alamo Pharmaceuticals

Treatment for Schizophrenia

Fazaclo is an orally disintegrating tablet which dissolves quickly in the mouth (without chewing or the need for water) indicated for the management of severely ill schizophrenic patients who fail to respond adequately to standard drug treatment for schizophrenia.

Date of Approval: February 9, 2004

Company: Solvay Pharmaceuticals

Treatment for Postmenopausal Symptoms

EstroGel is transdermal gel estrogen therapy for the treatment of moderate to severe vasomotor symptoms, as well as vulvar and vaginal atrophy associated with the menopause.

Company: ZLB Bioplasma AG, Switzerland

Treatment for Prevention of Rho(D) Sensitization

Date of Approval: February 12, 2004

Company: ImClone

Treatment for Colorectal Cancer

Erbitux is a monoclonal antibody indicated as a combination treatment to be given intravenously with irinotecan, or alone if patients cannot tolerate irinotecan. Erbitux is approved for the treatment of patients with advanced colorectal cancer that has spread to other parts of the body.

Date of Approval: February 26, 2004

Company: Genentech, Inc.

Treatment for Colorectal Cancer

Avastin is the first FDA-approved therapy designed to inhibit angiogenesis, the process by which new blood vessels develop, which is necessary to support tumor growth and metastasis. Avastin is used in combination with intravenous 5-Fluorouracil-based chemotherapy as a treatment for patients with first-line-or previously untreated-metastatic cancer of the colon or rectum.

Date of Approval: February 27, 2004

Company: Novartis Pharma AG

Treatment for Organ Transplant -- Rejection Prophylaxis

Myfortic is an enteric-coated formulation of mycophenolic acid for use in combination with cyclosporine and corticosteroids to prevent organ rejection in kidney transplant patients.