Wednesday, January 31, 2018
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.*
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).
Please refer to the full Prescribing Information, including Boxed Warning for Bumetanide Tablets, USP at http://bit.ly/Bumetanide-Safety. You can also call 1-888-650-3789 to obtain a copy of the full Prescribing Information.
You are encouraged to report suspected adverse reactions to Upsher-Smith Laboratories, LLC at 1-855-899-9180 or to the FDA by visiting http://www.fda.gov/medwatch.
