BERLIN, Oct. 29, 2007 (PRIME NEWSWIRE) -- Jerini AG (FSE:JI4) announced today the submission of its electronic New Drug Application (NDA) for Icatibant in the treatment of hereditary angioedema (HAE) to the U.S. Food and Drug Administration (FDA) as well as the company's request for priority review. Jerini has received technical clearance of its eCTD (Electronic Common Technical Document) from the agency, which ensures that the documentation meets the agency's technical standards. The FDA has up to 60 days to determine whether the application is complete and meets the regulatory requirements for filing. Priority review designation, which shortens the regulatory review period from ten to six months, will also be decided by the agency in this timeframe.
