Sweden's drug authority starts ProQuin review
California, USA-headquartered Depomed and Madaus Srl, the Italian subsidiary of the like named German drugmaker, say that a Marketing Authorization Application relating to the antibiotic ProQuin (ciprofloxacin HCl), an extended-release formulation similar to German firm Bayer HealthCare's Cipro (Marketletter May 30, 2005), has been accepted for review by the Swedish Medicinal Products Agency.
Madaus made the submission earlier this year, seeking approval for the product's use in the treatment of uncomplicated urinary tract infections. Danilo Casadei, vice president of corporate development at the firm, said that the first MAA submission had been challenging, but added that a positive response from Swedish regulators would smooth the road for subsequent European applications. The review is expected to take between nine and 12 months to complete.
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