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News: First Generic Ondansetron Injection Approved
November 23, 2006 - The FDA has approved the first generic versions of Zofran (Ondansetron) Injection and Zofran (Ondansetron) Injection Premixed. Ondansetron is indicated for the prevention of nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy... |
New Application: Herceptin
November 18, 2006 - The FDA have expanded the approved use of Herceptin, a biological cancer drug. The new indication is for Herceptin, in combination with other cancer drugs, for the treatment of HER2 positive breast cancer after surgery (lumpectomy or mastectomy). The FDA have granted priority review to the supplemental application for Herceptin... |
News: Pafuramidine Granted Orphan Drug Status
November 22, 2006 - Immtech Pharmaceuticals, Inc. announced today that the FDA has granted orphan drug designation for Pafuramidine to treat Pneumocystis jiroveci pneumonia (PCP). PCP is a common life-threatening opportunistic infection in HIV/AIDS and other immunosuppressed patients. This FDA Orphan Drug designation... |
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