ROCKVILLE, Md--The Food and Drug Administration approved 121 new original drugs in 1997 and 431 generic products. Median approval time for new original drugs was shortened by 6%, falling from 15.4 months in 1996 to 14.4 months in 1997.
The new entities approved included seven cancer drugs:
- Fareston (toremifene citrate, Schering-Plough), a once-daily oral antiestrogen, for the first-line treatment of metastatic breast cancer in postmenopausal women with estrogen-receptor-positive or receptor-unknown tumors.
- Femara (letrozole tablets, Novartis Pharmaceuticals Corporation), a once-daily aromatase inhibitor, for use in the treatment of postmenopausal women with advanced breast cancer that has progressed following the use of antiestrogen therapy.
- Rituxan (rituximab, IDEC/Genen-tech), the first monoclonal antibody approved for the treatment of cancer in the United States, is a single-agent treatment for follicular, CD-positive, B-cell non-Hodgkin’s lymphoma. Rituxan is given in four infusions over 22 days.
- Neumega (rhIL-11, American Home Products/Genetics Institute), the first biologic approved that promotes platelet production in patients with solid tumors or lymphoma who are undergoing chemotherapy.
- Quadramet (samarium Sm 153 lexidronam injection, Cytogen), a radiopharmaceutical for the amelioration of pain from cancers that have metastasized to bone. The agent can be administered as a single intravenous injection on an outpatient basis.
- Anzemet (dolasetron mesylate, Hoechst Marion Roussel), a selective
- 5-HT3 receptor antagonist for the prevention of nausea and vomiting in chemotherapy and surgery patients.
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Sclerosol Intrapleural Aerosol (sterile talc powder, Sciarra Laboratories) to treat malignant pleural effusions.
