SUCCESS STORIES:ORPHAN DRUG DESIGNATION GRANTED BY FDA

September 2011

IDIFARMA’s Regulatory Affairs staff contributed to the Orphan Drug designation recently granted by the FDA to Cardiotrophin-1 for Acute Liver Failure Treatment promoted by our client DIGNA BIOTECH. IDIFARMA also contributed in the preparation of the application for the designation of the Orphan Drug Status granted by the EMA in August 2011 to Cardiotrophin-1 for the same indication.

We congratulate DIGNA BIOTECH on this success and we thank them for acknowledging the work of IDIFARMA in their press release.

Click to download the press release.