Hikma receives approval of its NDA for Argatroban Injection, 100mg/mL vial

London, 9 January 2012 - Hikma Pharmaceuticals PLC (LSE: HIK) (NASDAQ Dubai: HIK) (“Hikma”), the fast growing multinational pharmaceutical group, today announces the approval of its New Drug Application (NDA) for argatroban injection, 100mg/mL vial by the US Food and Drug Administration (FDA).

Press Release Product 9 January 2012

Hikma’s argatroban is indicated for the prophylaxis or treatment of thrombosis in adult patients with heparin-induced thrombocytopenia (HIT) and as an anticoagulant in adult patients with or at risk of HIT undergoing percutaneous coronary intervention (PCI).

Said Darwazah, CEO of Hikma, said, “Argatroban will expand and strengthen our injectables product line and will help to differentiate our product portfolio in the US."

According to IMS Health, sales of argatroban injection were approximately $130 million for the 12 months ending November 2011.

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