Depomed, Madaus announce Swedish approval of ProQuin XR for urinary tract infections

By Lisa Kerner

Erie, Pa., March 29 - Depomed, Inc. and Madaus Srl said the Marketing Authorization Application (MAA) for ProQuin XR was accepted for review by the Medical Products Agency in Sweden.

Madaus submitted the MAA earlier this year, seeking approval for ProQuin XR, a once-daily, prolonged release formulation of ciprofloxacin hydrochloride developed by Depomed for the treatment of uncomplicated urinary tract infections.

"With the first ProQuin XR MAA under review in Sweden, Madaus has made its first step toward their goal of offering a once-daily ciprofloxacin product in Europe," Depomed chairman, president and chief executive officer John W. Fara said in a company news release.

The Swedish Medical Products Agency review should take between nine months and 12 months. Subsequent applications are expected to be filed in Germany, Spain, Italy, France and the United Kingdom, officials said.

ProQuin XR is commercially available in the United States through Esprit Pharma, Inc.

Located in Padova, Italy, Madaus is a privately owned specialty company with a focus on urology products.

Depomed is a specialty pharmaceutical company based in Menlo Park, Calif., that develops novel oral products and extended release formulations of existing oral drugs.

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