10 January 2020 - Acerus Pharmaceuticals today announced that the dossier filed as a decentralised Procedure in 19 European countries for the approval of Natesto has been withdrawn. 

The regulatory dossier was filed by our European licensee - medac Gesellschaft für klinische Spezialpräparate mbH (medac).

The MPA (Swedish Health Authority), the Reference Member State for the procedure, has requested that studies be completed, which were not otherwise required in other filings globally (including in Canada and the United States). 

After consulting with medac, we have mutually agreed to withdraw the application to allow for the completion of the studies. Subsequently it is aimed to re-submit the dossier with additional data.

Read Acerus Pharmaceuticals press release