June 23, 2008 - Jerini AG (FSE:JI4) announced today that following last week's communication with the US Food and Drug Administration (FDA), the company will submit a complete response to the FDA's not approvable letter for Icatibant in the treatment of acute attacks of hereditary angioedema (HAE). Jerini's complete response, to be submitted in the next three to four months, will provide the agency with information relating to Icatibant's efficacy in the treatment of HAE.
The details can be read here.
No comments:
Post a Comment