FDA rejects new indication for Spectrum drug
This is a discussion on FDA rejects new indication for Spectrum drug within the Biotechnology News forum, part of the Industry News and Updates category; The FDA declined to approve a supplementary marketing application for Spectrum Pharmaceuticals' cancer drug Fusilev. Currently approved for bone cancer, ...
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10-09-2009, 09:54 AM
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FDA rejects new indication for Spectrum drug
The FDA declined to approve a supplementary marketing application for Spectrum Pharmaceuticals' cancer drug Fusilev. Currently approved for bone cancer, the company was hoping it could expand the drug's indications to include advanced metastatic colorectal cancer. Spectrum said it will request a meeting with the agency to discuss further approval of the drug. The company's shares dropped 17 percent this morning on the news. Article
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