BioSante Announces FDA Orphan Drug Designation For GVAX Chronic Myeloid Leukemia Cancer Vaccine
BioSante Pharmaceuticals, Inc. has announced the receipt of Orphan Drug designation for GVAX CML Vaccine in the treatment of chronic myeloid leukemia (CML) from the FDA’s Office of Orphan Products Development. Orphan drug designation, as granted by the U.S. Orphan Drug Act, is for a product to treat a rare disease that affects almost 200,000 Americans. Orphan drug designation qualifies the sponsor of the product for tax credits and seven years of marketing exclusivity.
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The FDA has decided to postpone the approval for Genesense (oblimersen sodium) due to the lack of adequate data available for the drug. The drug is used in relapsed or refractory chronic lymphocytic leukemia. The Center for Drug Evaluation and Research (CDER) and the FDA agreed that the drug achieved the primary endpoint in the pivotal trial, drug maker