Depomed and Madaus S.r.l. Announce Acceptance of the Application for Approval of ProQuin(R) XR in Sweden.MENLO PARK, Calif. & PADOVA, Italy -- Depomed, Inc. (Nasdaq:DEPO DEPO Delegated Episcopal Pastoral Oversight DEPO Devils Postpile National Monument (US National Park Service) DEPO Defence Export Promotion Organization (Pakistan) DEPO Double Even Pass Odd ) and Madaus S.r.l. today announced that the Marketing Authorization Application (MAA MAA abbr. macroaggregated albumin ) for ProQuin(R) XR was accepted for review by the Medical Products Agency in Sweden. Madaus submitted the MAA earlier this year, seeking approval for ProQuin XR for the treatment of uncomplicated urinary tract infections. ProQuin XR is a once-daily, prolonged release formulation of ciprofloxacin hydrochloride ciprofloxacin hydrochloride Ciloxam, Cipro, Cipro I.V., Cipro XR, Ciproxin (UK) Pharmacologic class: Fluoroquinolone Therapeutic class: Anti-infective Pregnancy risk category C , which was developed by Depomed."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 ciprofloxacin /cip·ro·flox·a·cin/ (sip?ro-flok´sah-sin) a synthetic antibacterial effective against many gram-positive and gram-negative bacteria; used as the hydrochloride salt. cip·ro·flox·a·cin n. product in Europe," said John W. Fara, Ph.D., chairman, president and chief executive officer of Depomed. "The Swedish Medical Products Agency review is expected to take nine to 12 months." Danilo Casadei Massari, vice president, corporate development for Madaus added, "Our first European Marketing Authorization Application was the most challenging and we expect our completion of a suitable dossier for the commercial registration needs of Sweden will pave a smooth road for our subsequent applications in Germany, Spain, Italy, France and the United Kingdom, among others. ProQuin XR complements our existing product line and we look forward to offering patients this once-daily product, which is a powerful antibiotic, yet gentle on the gastrointestinal tract gastrointestinal tract n. The part of the digestive system consisting of the stomach, small intestine, and large intestine. Gastrointestinal tract ." About ProQuin(R) XR ProQuin XR is a once-daily prolonged-release formulation of ciprofloxacin hydrochloride approved to treat uncomplicated urinary tract infections (UTIs). UTIs are bacterial infections frequently caused by E. coli E. coli: see Escherichia coli. E. coli in full Escherichia coli Species of bacterium that inhabits the stomach and intestines. E. coli can be transmitted by water, milk, food, or flies and other insects. and are typically treated with antibiotics. Patients should not take ProQuin XR if they are allergic to, or have ever had a severe reaction to, ciprofloxacin or to any other "quinolone" antibiotics. ProQuin XR is generally well tolerated. The most common side effects Side effects Effects of a proposed project on other parts of the firm. with ProQuin XR include vaginal yeast infection Vaginal yeast infection An overgrowth of fungus in the vaginal area. Mentioned in: Jock Itch and headache. ProQuin XR is commercially available in the United States through Esprit Pharma, Inc. About Madaus Madaus is a privately owned specialty company with operations in Portugal, Spain, France, Germany, Italy, Benelux, Austria, Poland and collaborative arrangements with distributors in almost all other European countries. Madaus has a varied product portfolio targeting urology, including proprietary products such as Trospium Chloride. Urology is a primary focus for the company and Madaus' franchise in urology is strong. Madaus is one of the fastest growing pharmaceutical companies with aggregate sales in excess of 450 million Euro per year. About Depomed Depomed, Inc. is a specialty pharmaceutical company utilizing its innovative AcuForm(TM) drug delivery technology to develop novel oral products and improved, extended release formulations of existing oral drugs. AcuForm-based products are designed to provide once daily administration and reduced side effects, improving patient convenience, compliance and pharmacokinetic profiles. ProQuin(R) XR (ciprofloxacin hydrochloride) once daily, extended-release tablets have been approved by the FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. for the treatment of uncomplicated urinary tract infections. In addition, regulatory applications for once daily Glumetza(TM) for the treatment of Type II diabetes Type II diabetes Type II diabetes is the most common form of diabetes and usually appears in middle aged adults. It is often associated with obesity and may be delayed or controlled with diet and exercise. Mentioned in: Diabetic Ketoacidosis have been approved in the U.S. and Canada. The company completed a Phase II trial in post herpetic neuralgia neuralgia (n  răl`jə, ny–), acute paroxysmal pain along a peripheral sensory nerve. with its product, Gabapentin GR. Additional information about Depomed may be found at its web site, www.depomedinc.com. "Safe Harbor" Statement under the Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and of 1995. The statements that are not historical facts contained in this release are forward-looking statements that involve risks and uncertainties including, but not limited to, those related to our commercialization efforts and those of our collaborative partners, our research and development efforts, including pre-clinical and clinical testing; regulation by the FDA and other government agencies; the timing of regulatory applications and product launches; and other risks detailed in the company's Securities and Exchange Commission filings, including the company's Annual Report on Form 10-K. You are cautioned not to place undue reliance on these forward-looking statements which speak only as of the date hereof. The company undertakes no obligation to publicly release the result of any revisions to these forward-looking statements that may be made to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. |
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