Lannett announced that the Food and Drug Administration (FDA) has approved its Abbreviated New Drug Application (ANDA) for Neomycin Sulfate Tablets, the generic version of Teva’s listed reference drug. 

Neomycin Sulfate is an antibiotic indicated as adjunctive therapy as part of a regimen for the suppression of the normal bacterial flora of the bowel, (eg, preoperative preparation of the bowel); it is given concomitantly with erythromycin enteric-coated base. Also, it has been shown to be effective adjunctive therapy in hepatic coma by reducing the ammonia-forming bacteria in the intestinal tract. 

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Neomycin is bactericidal and acts by inhibiting the synthesis of protein in susceptible bacterial cells. It is effective primarily against gram-negative bacilli but does have some activity against gram-positive organisms. It is active in vitro against Escherichia coli and the Klebsiella-Enterobacter group; it is not active against anaerobic bowel flora.

Lannett’s Neomycin Sulfate Tablets will be available as a 500mg strength. The product is expected to launch in the next several months. 

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