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FDA Approvals - Xanthus Announces Oral Fludarabine NDA Accepted For Review By U.S.


Xanthus Announces Oral Fludarabine NDA Accepted For Review By U.S. FDA (Medical News Today)
Xanthus Pharmaceuticals, Inc., a privately-held oncology and autoimmune disease drug development company, announced that its New Drug Application (NDA) for fludarabine phosphate oral tablets (oral fludarabine) was accepted for filing by the U.S. Food and Drug Administration (FDA) for the treatment of relapsed B-cell chronic lymphocytic leukemia (CLL).

New Drug Application Submitted To FDA For Investigational Analgesic Tapentadol Immediate Release Tablets (Medical News Today)
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for tapentadol hydrochloride immediate release (IR) tablets, an investigational oral analgesic for the relief of moderate to severe acute pain.
 

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