Hikma receives FDA approval for Neostigmine Methylsulfate Injection
Hikma Pharmaceuticals PLC (“Hikma”) , 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.
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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 4 million for the 12 months ending November 2015.
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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."