Upsher-Smith Receives FDA Approval for Bumetanide Tablets, USP

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.*

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."

Product Information

             Product         Strength     NDC #     Package Size
             -------         --------     -----     ------------

     Bumetanide Tablets, USP  0.5 mg  0832-0540-11 100-ct Bottle
     -----------------------  ------  ------------ -------------

     Bumetanide Tablets, USP   1 mg   0832-0541-11 100-ct Bottle
     -----------------------   ----   ------------ -------------

     Bumetanide Tablets, USP   2 mg   0832-0542-11 100-ct Bottle
     -----------------------   ----   ------------ -------------

Upsher-Smith will be prepared to begin shipping product to wholesalers in early February 2018. For questions about ordering, please call Upsher-Smith at 1-800-654-2299.

                          WARNING

       See full Prescribing Information for complete
                        information.

    Bumetanide is a potent diuretic which, if given in
     excessive amounts, can lead to a profound
     diuresis with water and electrolyte depletion.
     Therefore, careful medical supervision is
     required, and dose and dosage schedule have to be
     adjusted to the individual patient's needs (see
     DOSAGE AND ADMINISTRATION).
    --------------------------------------------------

About Upsher-Smith
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