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news.TAP Pharmaceutical Products has submitted a new drug application to the FDA for the use of TAK-390MR, a proton pump inhibitor, in the treatment of acid-related diseases and treatment and maintenance of patients with erosive esophagitis and non-erosive reflux disease.
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The new drug application (NDA) filing is based on global studies conducted in more than 20 countries. These studies evaluated more than 6,000 subjects with erosive and non-erosive gastroesophageal reflux disease (GERD).
Nancy Ridge, vice president of R&D at TAP, said: “This compound and its novel delivery system is a promising next step in the management of erosive and non-erosive esophagitis. The development of TAK-390MR is another example of our experience and expertise in this therapeutic area and reinforces our commitment to patients.”