FDA approves Upsher-Smith’s generic Bumex

The Food and Drug Administration has approved Upsher-Smith’s generic Bumex (bumetanide) tablets. The drug is indicated to treat edema associated with congestive heart failure, hepatic disease and renal disease, including nephrotic syndrome.

Upsher-Smith’s generic Bumex is available in 0.5-, 1- and 2-mg dosage strengths, all of which are available in 100-count bottles. The company said it plans to launch the generic in February. The product had U.S. sales of $84.5 million for the 12 months ended November 2017, according to IQVIA data.

The approval follows a year that saw Upsher-Smith get acquired by Japan’s Sawai Pharmaceutical.

“Last year was an exciting one for Upsher-Smith,” president and CEO Rusty Field said. “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.”