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Lupin receives FDA approval for generic Nitrofurantoin Capsules USP

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Mumbai | Thursday, Jul 12 2018 IST
Pharma Major, Lupin said that it has received final approval for its Nitrofurantoin Capsules USP (Macrocrystals),50 mg and 100 mg from the United States Food and Drug Administration(FDA) to market a generic version of Alvogen Malta Operations Ltd.'s Macrodantin Capsules, 50 mg and 100 mg.

Lupin's Nitrofurantoin Capsules USP (Macrocrystals), 50 mg and 100 mg is the generic version of Alvogen Malta Operations Ltd.'s Macrodantin Capsules, 50 mg and 100 mg, company said in a filing with BSE. It is specifically indicated for the treatment of urinary tract infections (UTI) when due to susceptible strains of Escherichia coli, enterococci, Staphylococcus aureus, and certain susceptible strains of Klebsiella and Enterobacter species.

Nitrofurantoin Capsules USP (Macrocrystals), 50 mg and 100 mg had annual sales of approximately USD 27 million in the US (IQVIA MAT April 2018).

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