New FDA Approvals
New FDA Approvals
These drugs recently received final approval from the Food and Drug Administration (FDA):
• Zoledronic acid for injection (Zometa) by Novartis. The FDA has approved zoledronic acid for injection (Zometa) for the treatment of patients with multiple myeloma and patients with documented bone metastases from solid tumors, in conjunction with standard antineoplastic therapy. These solid tumors include prostate cancer, lung cancer, breast cancer, and other solid tumor types. In prostate cancer, patients should have progressed after treatment with at least one hormonal therapy.
The trials that led to the approval of zoledronic acid for injection mark represent the first time any bisphosphonate has demonstrated efficacy in treating bone complications in patients with prostate cancer, lung cancer, and other solid tumors. Further, zoledronic acid for injection offers patients, nurses, and clinicians a 4 mg,
15-minute infusion time.
• A new indication for clopidogrel bisulfate (Plavix) by Sanofi-Synthelabo and Bristol-Myers Squibb Co. The FDA has approved the antiplatelet medication clopidogrel bisulfate (Plavix) for a new indication: acute coronary syndrome. Clopidogrel bisulfate is already approved for use in patients with a history of recent heart attack, recent stroke, or established peripheral arterial disease.
• A new indication for infliximab (Remicade)
by Centocor. The FDA has approved the use of infliximab (Remicade) with methotrexate for the treatment of rheumatoid arthritis in patients who have had an inadequate response to methotrexate alone. Remicade is the first monoclonal antibody used to reduce the signs and symptoms of rheumatoid arthritis and is administered intravenously at zero, two, and six weeks initially and every eight weeks thereafter. After the first year, patients are scheduled to receive six infusions a year. Remicade was previously approved for the treatment of Crohn’s disease in August 1998.
• HIV-1/HCV Assay (Procleix) by Chiron Corp. The FDA has approved the HIV-1/HCV Assay (Procleix) for human immunodeficiency virus type 1 (HIV-1) and hepatitis C virus (HCV). The nucleic acid amplification test (NAT) is designed to detect the presence of all known HIV-1 subtypes and HCV genotypes in whole blood during the very early stages of infection, when those agents appear but cannot be detected by immunodiagnostic screening technologies.
• Interferon beta-1a (Rebif) by Serono, S.A. The FDA has approved interferon beta-1a (Rebif) for the treatment of relapsing forms of multiple sclerosis. This approval was based upon the results of two large multicenter studies in patients with relapsing remitting multiple
sclerosis.
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