UPPER-SMITH LABORATORIES, INC: Upsher-Smith Receives FDA Approval for Bumetanide Tablets, USP

Upsher-Smith Laboratories, Inc issued the following announcement on Jan. 30.

Upsher-Smith Laboratories, LLC (Upsher-Smith) 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.

Original source can be found here.

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Organizations in this story

Upsher-Smith Laboratories, Inc 6701 Evenstad Dr Maple Grove, MN 55369