The FDA is requesting additional information prior to AcuCort's registration application in the United States
The American agency FDA (U.S. Food and Drug Administration) has announced that AcuCort needs to submit additional information prior to the company's registration application in the United States. This also extends the time for the exemption from registration fee that was previously communicated.AcuCort has been informed by the American authority FDA that additional documentation is required by the company for its registration application in the United States regarding the drug Zeqmelit®. The company does not see that it would change a positive outcome of the application. With the