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  • If the MFDS followed the EMA instead of the FDA for Belviq
  • by Lee, Tak-Sun | translator Choi HeeYoung | Feb 19, 2020 06:33am
The EMA rejected approval in 2013 due to tumor induction
The US FDA Approved June 2012, In Korea, all product licenses were granted in February 2015
By 2018, cumulative sales up to 50 billion, cancer concerns labels only started last year
 ¡ã Appetite suppressant
At the time of approving Belviq, banned by the MFDS on the 14th, it would be regrettable that it had not been approved in accordance with the European EMA's decision.

The European EMA disagreed with the approval due to side effects from animal testing, and the developer voluntarily withdrew the application.

The US FDA, on the other hand, approved it in June 2012, subject to post-marketing studies on cardiovascular risk.

Belviq was licensed in Korea through Ildong, an importer, in February 2015. In April of last year, Belviq XR was approved.

Belviq was designated for re-examination at the time of domestic approval and was ordered for post-marketing investigation for six years from February 2015 to Februar
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