KapidexTreatment for Erosive Esophagitis, Gastroesophageal Reflux Disease
Update: Kapidex Now FDA Approved - January 30, 2009
TAP Pharmaceutical Products Inc. Files New Drug Application for TAK-390MR in Patients with Acid-Related Disorders
LAKE FOREST, Ill., January 03, 2008 /PRNewswire/ -- TAP Pharmaceutical Products Inc. today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for the use of TAK-390MR in the treatment of acid related diseases and treatment and maintenance of patients with erosive esophagitis and non-erosive reflux disease. TAK-390MR is a proton pump inhibitor that utilizes a novel delivery system.
"This compound and its novel delivery system is a promising next step in the management of erosive and non-erosive esophagitis," said Nancy Joseph Ridge, M.D., vice president of research and development at TAP. "The development of TAK-390MR is another example of our experience and expertise in this therapeutic area and reinforces our commitment to patients."
The NDA filing, which was entirely electronic (eCTD) from data collection to submission, is based on global studies conducted in more than 20 countries. These studies evaluated more than 6,000 subjects with erosive and non-erosive GERD.
About TAP Pharmaceutical Products Inc.
TAP Pharmaceutical Products Inc., located in Lake Forest, Ill., is a joint venture between Abbott, headquartered in Abbott Park, Ill., and Takeda Pharmaceutical Company Limited, of Osaka, Japan. TAP markets Prevacid(R) and Lupron Depot(R) (leuprolide acetate for depot suspension). For more information about TAP Pharmaceutical Products Inc., and its products, visit the company's web site at http://www.tap.com.
CONTACT: Media, Amy Martin, +1-847-582-6019, or Geoff Curtis,+1-312-284-4701, both for TAP Pharmaceutical Products Inc.
Web site: http://www.tap.com/
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Posted: January 2008
- FDA Approves Kapidex (dexlansoprazole) for the Treatment of GERD - February 2, 2009
- FDA Adds Three Months to Review of Takeda's New Drug Application for TAK-390MR - October 20, 2008