12th Mar 2014 10:31
LONDON (Alliance News) - Sinclair IS Pharma PLC said Wednesday that its dermal burn cream Flammacerium had been granted orphan drug designation by the US Food and Drug Administration.
This designation grants Sinclair marketing exclusivity for seven years following approval.
Sinclair noted that it must now be granted marketing approval by the FDA for the US. It expects this approval to provide a, "material upside" to its earnings in the future.
"Sinclair is optimistic to receive US approval in due course and potentially within an accelerated time frame from regulatory filing," said Chief Executive Officer Chris Spooner in a statement.
Shares in Sinclair were trading up 1.3% at 29.00 pence Wednesday morning.
By Hana Stewart-Smith; [email protected]; @HanaSSAllNews
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