BTG plc: Varisolve® NDA accepted for full review by FDA
London, UK, 12 April 2013: BTG plc (LSE: BTG), the specialist healthcare company, announces that the New Drug Application (NDA) seeking approval of Varisolve® (polidocanol endovenous microfoam (PEM)) as a comprehensive treatment for varicose veins, which was submitted to the US Food & Drug Administration (FDA) on 4 February 2013, has been accepted for full review by the FDA.
Based on standard review timelines, BTG anticipates potential US approval and launch of PEM during H1 2014.
For further information contact:
Andy Burrows, Director of Investor Relations
+44 (0)20 7575 1741; Mobile: +44 (0)7990 530605
Rolf Soderstrom, Chief Financial Officer
+44 (0)20 7575 0000
Ben Atwell/Simon Conway
+44 (0)20 7831 3113
BTG is an international specialist healthcare company that is developing and commercialising products targeting critical care, cancer and other disorders. The company has diversified revenues from sales of its own marketed products and from royalties on partnered products, and is seeking to acquire new programmes and products to develop and market to specialist physicians.