29th Sep 2014 09:23
LONDON (Alliance News) - Clinigen Group PLC said Monday that it has received the first Drug Shortage Assistance Award from the US Food and Drug Administration for its contribution in addressing a US shortage of Foscavir injection.
The company is the first to receive the award, won in relation to its efforts to combat the US shortage of the Foscavir (foscarnet sodium) injection. Clinigen said action taken to address the shortage included making the drug available on a named patient basis whilst acquiring the new drug application and submitting post-approval supplements to restart manufacturing with acceptable compliance records, resolving a critical drug shortage affecting patients.
"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," said Chief Executive Peter George.
Shares in Clinigen Group were Monday morning trading 0.55% higher at 453.00 pence per share.
By Alice Attwood; [email protected]; @AliceAtAlliance
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