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These drugs recently received final approval from the Food and Drug Administration (FDA):
• Capecitabine (Xeloda) by Roche in combination with docetaxel (Taxotere) by Aventis. The FDA has approved a combination of the cancer drugs Xeloda and Taxotere for treating patients with metastatic breast cancer whose cancer has progressed after treatment with an anthracycline-containing cancer therapy (such as Adriamycin and doxorubicin). Xeloda, an oral cancer therapy initially was approved for breast cancer on April 30, 1998. Taxotere, an intravenous product, was approved for treating advanced breast cancer on May 15, l998.
• Verteporfin for injection (Visudyne) by Novartis Ophthalmics and QLT. The FDA has approved Visudyne therapy for the treatment of predominantly classic subfoveal choroidal neovascularization (CNV) due to pathologic myopia (severe nearsightedness) and presumed ocular histoplasmosis. Visudyne is the only drug treatment approved for these eye conditions. Visudyne was approved in April 2000 in the United States and since has been launched in almost 50 countries for the treatment of predominantly classic CNV caused by age-related macular degeneration.
• Nesiritide (Natrecor) by Scios. Natrecor has been approved by the FDA for the intravenous treatment of patients with acutely decompensated congestive heart failure who have shortness of breath at rest or with minimal activity. Natrecor is a recombinant form of human B-type natriuretic peptide (hBNP), a naturally occurring hormone secreted by the ventricles. It is the first of this drug class to be made available as a therapeutic for human disease in the United States. Scios anticipates launching the drug in U.S. hospitals by the end of August.
• Acetaminophen and tramadol HCl (Ultracet) by Ortho-McNeil Pharmaceutica. Ultracet (37.5 mg tramadol hydrochloride/325 mg acetaminophen tablets) has been approved by the FDA for the short-term (five days or less) management of acute pain. This medication is a centrally acting analgesic that controls pain through different mechanisms of action than nonsteroidal anti-inflammatory drugs (NSAIDs), the most commonly used pain medications. As a result, Ultracet is not associated with the side effects that can result from NSAID use, such as gastrointestinal ulcers or bleeding.
• Granisetron Solution (Kytril) by Hoffmann-La Roche. Kytril been approved for the prevention of nausea and vomiting associated with initial and repeat courses of cancer therapy, including high-dose cisplatin, and nausea and vomiting associated with radiation, including total body irradiation and fractionated abdominal radiation. Kytril is currently available in both tablet and injection formulations.