FDA approves BWXT's radiopharmaceutical

By AuntMinnie.com staff writers

September 26, 2019 -- 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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