Upsher-Smith Laboratories has received U.S. Food and Drug Administration (FDA) approval of its abbreviated new drug application (ANDA) for Bumetanide Tablets, USP, 0.5 mg, 1 mg, and 2 mg. Bumetanide Tablets are a generic version of the brand product, Bumex (bumetanide) Tablets.
The bumetanide tablet market had U.S. sales of approximately $84.5 million for the 12 months ending November, 2017 according to IMS Health.
"Last year was an exciting one for Upsher-Smith," said Rusty Field, President and CEO of Upsher-Smith. "We were part of one of the largest pharmaceutical transactions of the year and continued to expand our generic product portfolio. We are pleased to begin this year by adding Bumetanide Tablets to our portfolio of quality generic products."