Kedrion announces that on 3rd June 2011 it has received from the Food and Drug Administration, the government agency responsible for supervising and authorising the marketing of pharmaceuticals in the United States, the authorisation to sell its albumin on the US market, with the brand name KEDBUMIN.
Under such authorisation, Kedrion will produce albumin for the US market at its production plant in Bolognana, Lucca (Italy). The plant was inspected by FDA in March this year, with such inspection covering the purification, primary and secondary packaging units as well as the Quality Assurance and Quality Control departments. The inspection was part of the procedure for release of the BLA (Biologic License Application), as prescribed for registering biological products in the United States.
The registration proceedings began in January 2009, when Kedrion submitted to FDA an application for a pre-IND meeting (the stage at which information about a drug is reviewed as a prerequisite for issuing an authorisation or starting clinical studies if needed), which was followed, on 30th July 2010, by an official request for a Biologic License Application from FDA. The drug will be launched on the US market in the last quarter of 2011.