Navigation Links
FDA Adds Three Months to Review of Takeda's New Drug Application for TAK-390MR

Compound is a member of PPI class for treatment for GERD and Erosive


OSAKA, Japan, Oct. 20 /PRNewswire/ -- Takeda Pharmaceutical Company Limited ("Takeda") today announced that Takeda Global Research and Development Center, Inc., a wholly owned United States (U.S.) subsidiary received notification from the U.S. Food and Drug Administration (FDA) that the agency will not be able to complete its review of the TAK-390MR New Drug Application (NDA) by the original Prescription Drug User Fee Act (PDUFA) date in October, 2008.

"The FDA informed Takeda that it will require an additional three months to complete the review of the TAK-390MR NDA," said Dean Sundberg, senior vice president, regulatory affairs at Takeda Global Research and Development Center, Inc. "Takeda has been very responsive to all questions posed during the review cycle. Such dialogue between a sponsor company and the FDA is common during the review of any NDA. The FDA needs this time to review the total package of information contained in the NDA. Takeda will continue to work with the FDA for completion of the review by the revised date. Takeda is confident TAK- 390MR will be an important new treatment option for people living with GERD and erosive esophagitis."

TAK-390MR, an investigational compound, is currently under review with the U.S. Food and Drug Administration (FDA) for once-daily, oral treatment of daytime and nighttime heartburn and other symptoms of Gastroesophageal Reflux Disease (GERD), the healing of erosive esophagitis (EE) and the maintenance of healed erosive esophagitis. The New Drug Application (NDA) for TAK-390MR, submitted in December 2007, was based on global studies conducted in 20 countries, in approximately 6,000 patients with erosive and non-erosive GERD.

About Takeda Pharmaceutical Company Limited

Located in Osaka, Japan, 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. Additional information about Takeda is available through its corporate website,

SOURCE Takeda Pharmaceutical Company Limited
Copyright©2008 PR Newswire.
All rights reserved

Related medicine news :

1. Plexus Systems Ranks in Top Third of the 2007 Inc. 5,000 with Three-Year Sales Growth of 226%
2. Best Practice Database: Complimentary Excerpt of Three Sales Force Excellence Studies
3. Lorus Therapeutics announces election of three new Directors and appoints a new Chairman
4. Portico Systems Wins Three Awards in 30 Days
5. Three Batesville Casket Company Production Facilities Honored for Manufacturing Expertise by National Organizations
6. Unions File Charges Against Tenet Healthcare Corporation, Three Northern California Hospitals
7. Introduces Three New Free Services: Health Business Daily Newsletter, Health Business Meeting Calendar, and Health Care Job Openings
8. Sign Up Now for Project Management Essentials - Three Days of Training in IT Project Management Fundamentals
9. Medco Unveils Three New Medicare Prescription Drug Plan Options for 2008 to Provide Seniors More Choice, Better Value and Specialist Pharmacists
10. ReBuilder Medical Technologies, Inc. Increases Staffing by 30% in Three Weeks Due to Increase in Demand for All ReBuilder Medical Products
11. Brain, Eye and Heart Health: Three Reasons to Eat More Omega-3s
Post Your Comments:
(Date:6/25/2016)... ... June 25, 2016 , ... Experts from the ... AcademyHealth’s Annual Research Meeting June 26-28, 2016, at the Hynes Convention Center in ... topics including advance care planning, healthcare costs and patient and family engagement. , ...
(Date:6/25/2016)... ... June 25, 2016 , ... "With 30 hand-drawn hand gesture animations, FCPX ... Austin - CEO of Pixel Film Studios. , ProHand Cartoon’s package transforms over ... Cut Pro X . Simply select a ProHand generator and drag it above media ...
(Date:6/25/2016)... ... June 25, 2016 , ... Dr. Calvin Johnson has dedicated ... has implemented orthobiologic procedures as a method for treating his patients. The procedure ... doctors to perform the treatment. Orthobiologics are substances that orthopaedic surgeons use to ...
(Date:6/24/2016)... ... June 24, 2016 , ... A recent article published June ... with. The article goes on to state that individuals are now more comfortable seeking ... common operations such as calf and cheek reduction. The Los Angeles area medical group, ...
(Date:6/24/2016)... ... ... was in a crisis. Her son James, eight, was out of control. Prone to extreme ... “When something upset him, he couldn’t control his emotions,” remembers Marcy. “If there was ... other children and say he was going to kill them. If we were driving ...
Breaking Medicine News(10 mins):
(Date:6/23/2016)... -- Research and Markets has announced the addition ... - Forecast to 2022" report to their offering. ... to date financial data derived from varied research sources to ... potential impact on the market during the next five years, ... of sub markets, regional and country level analysis. The report ...
(Date:6/23/2016)... Research and Markets has announced the ... report to their offering. ... favourable commercial environment for MedImmune to enter. The US ageing ... serve to drive considerable growth for effective anti-influenza medications. The ... sales considerably, but development is still in its infancy. ...
(Date:6/23/2016)... , June 23, 2016 , ... on Thursday, July 7, 2016 , , , , LOCATION: ... , , , , EXPERT PANELISTS:  , , , ... Senior Industry Analyst, Christi Bird; Senior Industry Analyst, Divyaa Ravishankar and ... The global pharmaceutical industry is witnessing an exceptional era. ...
Breaking Medicine Technology: