New Drug Approvals Archive
New Drug Approvals: November 2004
| November 5 | TriCor () Tablets Company: Abbott Laboratories Treatment for Lipid Disorders TriCor Abbott Laboratories - Treatment for Lipid Disorders |
| November 10 | Omacor (omega-3-acid ethyl esters) Capsules Date of Approval: November 10, 2004 Company: Reliant Pharmaceuticals, Inc. Treatment for Hypertriglyceridemia Omacor, which contains highly concentrated ethyl esters of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), is indicated as an adjunct to diet for the reduction of triglycerides in adult patients with very high triglyceride levels. Omacor Reliant Pharmaceuticals, Inc. - Treatment for Hypertriglyceridemia |
| November 17 | Atrovent HFA (ipratropium bromide) Inhalation Aerosol Date of Approval: November 17, 2004 Company: Boehringer Ingelheim Treatment for Bronchospasm Prophylaxis Atrovent HFA is an environmentally friendly version of Atrovent formulated with a non-chlorofluorocarbon (CFC) propellant called HFA (hydrofluoroalkane). Atrovent HFA is indicated as a bronchodilator for maintenance treatment of bronchospasm associated with COPD (chronic obstructive pulmonary disease), including chronic bronchitis and emphysema. Atrovent HFA Boehringer Ingelheim - Treatment for Bronchospasm |
| November 18 | Tarceva () Tablets Date of Approval: December 31, 1969 Company: OSI/Genentech Treatment for Non-Small Cell Lung Cancer Tarceva OSI/Genentech - Treatment for Non-Small Cell Lung Cancer |
| November 18 | Tarceva () Tablets Date of Approval: December 31, 1969 Company: OSI/Genentech Treatment for Non-Small Cell Lung Cancer Tarceva OSI/Genentech - Treatment for Non-Small Cell Lung Cancer (NSCLC) |
| November 19 | Vesicare () Tablets Company: Yamanouchi / GlaxoSmithKline Treatment for Overactive Bladder Vesicare Yamanouchi / GlaxoSmithKline - Treatment for Overactive Bladder |
| November 23 | Tysabri (natalizumab) Injection - formerly Antegren Company: Biogen Idec / Elan Corporation, plc Treatment for Multiple Sclerosis Tysabri Biogen Idec / Elan Corporation, plc - Treatment for Multiple Sclerosis |
| November 26 | Combunox (ibuprofen and oxycodone hydrochloride) Tablets Date of Approval: November 26, 2004 Company: Forest Laboratories, Inc. Treatment for Pain Combunox is a fixed-dose combination of the opioid oxycodone HCl (5 mg) and the nonsteroidal anti-inflammatory drug (NSAID) ibuprofen (400 mg) indicated for the short-term management of acute, moderate to severe pain. Combunox Forest Laboratories, Inc. - Treatment for Moderate to Severe Pain |
| November 30 | Antara (fenofibrate) Capsules Date of Approval: November 30, 2004 Company: Reliant Pharmaceuticals, Inc. Treatment for Heterozygous Familial Hypercholesterolemia, Hypertriglyceridemia Antara is a lipid-lowering agent approved as adjunctive therapy to diet for the treatment of elevated levels of cholesterol and triglycerides. Antara Reliant Pharmaceuticals, Inc. - Treatment for Hypercholesterolemia and Hypertriglyceridemia |
| November 30 | Clindesse (clindamycin phosphate) Vaginal Cream Date of Approval: November 30, 2004 Company: KV Pharmaceutical Company Treatment for Bacterial Vaginosis Clindesse Vaginal Cream 2% is a single-dose prescription cream therapy indicated to treat bacterial vaginosis. Clindesse KV Pharmaceutical Company - Treatment for Bacterial Vaginosis |
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