New Drug Approvals Archive
New Drug Approvals: February 2004
| February 4 | Alimta (pemetrexed) Injection Date of Approval: February 4, 2004 Company: Eli Lilly Treatment for Malignant Pleural Mesothelioma, Non-Small Cell Lung Cancer Alimta is an antifolate antineoplastic agent indicated for the treatment of malignant pleural mesothelioma and locally-advanced and metastatic non-small cell lung cancer (NSCLC). FDA Approves Alimta for Malignant Pleural Mesothelioma |
| February 5 | Clobex (clobetasol propionate) Lotion 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. Clobex Galderma Laboratories - Treatment for Scalp Psoriasis |
| February 5 | Orthovisc (sodium hyaluronate) Injection 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. Orthovisc Anika Therapeutics, Inc. - Treatment for Osteoarthritis of the Knee |
| February 9 | Fazaclo (clozapine) Orally Disintegrating Tablets 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. Fazaclo Alamo Pharmaceuticals - Treatment for Schizophrenia |
| February 9 | EstroGel (estradiol topical) Gel 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. EstroGel Solvay Pharmaceuticals - Treatment for Menopausal Vasomotor Symptoms |
| February 12 | Rhophylac () Immune Globulin Intravenous - Human) Injection Company: ZLB Bioplasma AG, Switzerland Treatment for Prevention of Rho(D) Sensitization Rhophylac ZLB Bioplasma AG, Switzerland - Treatment for Prevention of Rho(D) Sensitization |
| February 12 | Erbitux (cetuximab) Injection 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. Erbitux ImClone - Treatment for Advanced Colorectal Cancer |
| February 26 | Avastin (bevacizumab) Injection Date of Approval: February 26, 2004 Company: Genentech, Inc. Treatment for Colorectal Cancer, Non-Small Cell Lung Cancer, Breast Cancer Avastin is a recombinant humanized monoclonal IgG1 antibody for the treatment of metastatic colorectal cancer, non-small cell lung cancer and HER2-negative breast cancer. Avastin Approved for treatment for Metastatic Colorectal Cancer |
| February 27 | Myfortic (mycophenolic acid) Tablets 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. Myfortic Novartis Pharma AG - Treatment for Prevention of Organ Rejection |
New Drug Approvals Archive
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