After the authorities issued a notice on conducting clinical reevaluations for the active ingredient formoterol fumarate, Sama Pharm, the only company that maintained its authorization for the ingredient, was found to have submitted a clinical trial protocol for its acute bronchitis indication among its 3 approved indications (bronchial asthma, acute bronchitis, asthmatic bronchitis).

The Ministry of Food and Drug Safety ordered clinical reevaluations to be conducted for 16 tablet and syrup products that contain formoterol fumarate on December 23, 2020 and requested companies to submit their clinical trial protocols by March 31, 2021.

However, all companies that own items other than the