East Windsor, N.J. – Aurobindo Pharma Limited has received final approval from U.S. Food and Drug Administration for its Abbreviated New Drug Application Fosfomycin Tromethamine Granules for Oral Solution, 3 grams (Single-Dose Sachet). Aurobindo Pharma’s Fosfomycin Tromethamine Granules for Oral Solution, are an AB-rated generic equivalent to the reference listed drug (RLD), Monurol® Granules for Oral Solution manufactured by Zambon S.p.A.

Fosfomycin Tromethamine Granules for Oral Solution are indicated only for:

• The treatment of uncomplicated urinary tract infections (acute cystitis) in women due to susceptible strains of Escherichia coli and Enterococcus faecalis.