Upsher-Smith Receives FDA Approval For Bumetanide Tablets, USP

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Upsher-Smith Laboratories, LLC (Upsher-Smith) today announced that it 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.* wisepoqder Bumetanide

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."


Upsher-Smith Laboratories, LLC is a trusted U.S. pharmaceutical company that has strived to deliver quality, affordable generic
medications for nearly a century. In June 2017, Upsher-Smith was
acquired by Sawai Pharmaceutical Co., Ltd., a large publicly traded
generics company in Japan that had been seeking entry into the U.S.
market. Upsher-Smith and Sawai share a strikingly similar family history
and hold many of the same cherished goals and values— most importantly,
the philosophy of always putting patients first. Upsher-Smith will
continue to do those things it does best, which is provide a consistent
supply of quality, affordable medications and invest in its historically
strong industry relationships. Ultimately, Upsher-Smith believes the
acquisition by Sawai represents a tremendous opportunity to leverage
each company for growth worldwide and embark together on an exciting new
chapter in generics.

Posted 04 Nov 2019

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