The American agency FDA (U.S. Food and Drug Administration) has announced that AcuCort AB (publ) 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 extended processing time that the supplement entails, AcuCort has also had the date for the last submission under the Small Business Waiver brought forward. This also extends the time for exemption from the registration fee of USD 1.6 million, approximately SEK 16.7 million.

A new Small Business Waiver application deadline has not yet been provided to AcuCort. AcuCort will notify the market as soon as additional information is approved by the FDA and a new registration deadline has been communicated by the authority.