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  • Clinical re-evaluation is being reviewed for Formoterol
  • by Lee, Tak-Sun | translator Choi HeeYoung | Nov 19, 2020 06:10am
On the 23rd, the Central Pharmaceutical Affairs Review Committee will discuss the decision, the need for a renewal examination appears to have been raised
Approval of 17 items including Sama's Atock, excluding inhalants with high market share
The MFDS is reviewing a clinical re-evaluation of Formoterol Fumarate Hydrate tablets and syrups used to treat asthma.

This is because the need for validation was raised during the renewal review process. However, the policy is to finalize the re-evaluation through the Central Pharmaceutical Affairs Review Committee.

According to the MFDS on the 16th, the Central Pharmaceutical Affairs Review Committee meeting will be held on the 23rd to review whether a clinical re-evaluation of Formoterol fumarate Hydrate will be conducted.

Formoterol Fumarate Hydrate is primarily used for asthma. It is mainly composed of inhalants, syrup, and tablets, but the targets of this re-evaluation are syrups and tablets.

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