FDA approves BWXT's radiopharmaceutical

2016 04 11 16 41 58 174 Approved Stamp 200

U.S. government nuclear components supplier BWX Technologies (BWXT) has received approval from the U.S. Food and Drug Administration (FDA) for its abbreviated new drug application (NDA) for a generic version of indium-111 (In-111) oxyquinoline solution.

The NDA was submitted by BWXT's subsidiary, BWXT ITG Canada, for the use of In-111 oxyquinoline for radiolabeling autologous leukocytes. FDA approval allows BWXT to market and distribute In-111 oxyquinoline in the U.S. The radiopharmaceutical also is BWXT ITG Canada's first generic product to come to market.

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