Clinigen receives top US award for making important drug more widely available

STAFFORDSHIRE pharmaceutical group Clinigen has received a top new US award in recognition of its efforts to make a pioneering new drug more widely available.

The Burton-upon-Trent group has received the Drug Shortage Assistance Award from the Food and Drug Administration (FDA) for addressing a US shortage of Foscavir® (foscarnet sodium) injection.
 
Clinigen’s efforts included making Foscavir® available on a named patient basis whilst acquiring the new drug application and submitting post-approval supplements to restart manufacturing with acceptable compliance records. The FDA said by its actions, Clinigen had resolved a critical drug shortage.
 
This award also recognises companies for their commitment to public health, as well as to quality manufacturing and is the first time the award has been made by the FDA.
 
Peter George, Chief Executive Officer, Clinigen Group, said: “To be the recipient of this new award from the FDA is a great honour and absolutely reflects Clinigen’s mission to ensure that the right drug reaches the right patient at the right time.  

“Since acquiring Foscavir® from AstraZeneca in 2010, we have worked hard to expand the indications and markets for the drug to increase the number of patients who can benefit. It is a real compliment that the FDA is committed to working with companies, like Clinigen, to prevent and mitigate drug shortages.”