Hikma receives FDA approval for Neostigmine Methylsulfate Injection

London, 4 January 2016 – Hikma Pharmaceuticals PLC ("Hikma") (LSE: HIK) (NASDAQ Dubai: HIK) (OTC: HKMPY), (rated Ba1 Moody's / BB+ S&P, both stable), the fast growing multinational pharmaceutical group, announces that its Abbreviated New Drug Application ("ANDA") for Neostigmine Methylsulfate Injection USP, 5 mg/10 mL and 10 mg/10 mL, multiple-dose vials has been approved by the U.S. Food and Drug Administration ("FDA")  and that it has launched this product in the US market.

Neostigmine Methylsulfate injection, a cholinesterase inhibitor, is indicated for reversal of the effects of non-depolarizing neuromuscular blocking agents (NMBA) after surgery. According to IMS Health, sales of Neostigmine Methylsulfate Injection in the US market were approximately $264 million for the 12 months ending November 2015.

Said Darwazah, Chairman and CEO of Hikma, said, "This approval demonstrates our strong regulatory capabilities and the successful execution of our strategy to develop a more differentiated injectable product portfolio."

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