Withdrawal of application for the marketing authorisation of Dabigatran etexilate

This withdrawal of application may be related to the nitrosamine issues.

How far into the evaluation was the application when it was withdrawn?
The application was withdrawn after the European Medicines Agency had evaluated the information from the company and prepared questions for the company. After the Agency had assessed the company’s responses to the last round of questions, there were still some unresolved issues.

What did the Agency recommend at that time?
Based on the review of the data and the company’s response the Agency’s questions, at the time of the withdrawal, concerns remained on the presence of nitrosamine impurities in the medicine and its provisional opinion was that Dabigatran etexilate Teva could not have been authorised for the requested indication.

Therefore, at the time of the withdrawal, the Agency’s opinion was that the benefits of Dabigatran etexilate Teva did not outweigh its risks.

I can’t know about the truth of the cause of withdrawal.
N-nitroso Dabigatran should be reduced under 5 ppm in japan. It’s seemed to be hard to cotrol though the AI limit was mitigated from 400 μg/day to 1,500μg/day.