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Pharma & Bio Ingredients
The companies said they expect the review by Sweden's Marketing Authorization Agency to take nine months to a year.
ProQuin XR, is a once-daily, prolonged-release antibiotic used to treat uncomplicated urinary tract infections, which are generally caused by E. coli and other bacteria. The antibiotic was developed by DepoMed, and the company agreed to commercialize it through Madaus in November.
Madaus said this marketing authorization application for the drug was the most challenging because it is the first, and should smooth the way for subsequent applications in other European countries.
