Generic medication company Upsher-Smith Laboratories LLC reported on Tuesday the receipt of approval from the US Food and Drug Administration (FDA) for its abbreviated new drug application (ANDA) for Bumetanide Tablets, USP in 0.5 mg, 1 mg and 2 mg for treating fluid retention in the body.
According to the company, Bumetanide Tablets are a generic version of the brand product, Bumex (bumetanide) Tablets.
The company will begin shipping Bumetanide Tablets to wholesalers in early February 2018.
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, added the company.
For the 12 months ending November 2017, the bumetanide tablet market had US sales of approximately USD84.5m, according to IMS Health.
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