TAP Pharmaceutical Products Inc, a joint venture between Takeda Pharmaceutical Company Limited and Abbott Laboratories, had submitted a New Drug Application (NDA) to the US Food and Drug Administration for TAK-390MR, a proton pump inhibitor.
TAK-390MR employs a novel modified release technology on dexlansoprazole discovered by Takeda. The NDA submission this time is for the use of TAK-390MR in the treatment and maintenance of patients with erosive esophagitis and non-erosive reflux disease, and 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.
"We are very much pleased with the NDA submission of TAK-390MR," said Yasuchika Hasegawa, president, Takeda. "We expect TAK-390MR will contribute as a novel treatment option for the patients with such acid related disorders and healthcare provides who treat them, and also will enhance TAP's well established gastroenterology franchise in the US marketplace once approved."
Takeda is a research-based global company with its main focus on pharmaceuticals. As the largest pharmaceutical company in Japan and one of the global leaders of the industry, Takeda is committed to striving toward better health for individuals and progress in medicine by developing superior pharmaceutical products.