Hikma gets FDA approval for neostigmine methylsulfate injection generic

Jordan-based drugmaker Hikma Pharmaceuticals (LSE: HIK) revealed this morning that its Abbreviated New Drug Application for neostigmine methylsulfate injection USP, multiple-dose vials has been approved by the US Food and Drug Administration 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. The reference drug is marketed under the Bloxiverz trade name by Flamer Technologies (Nasdaq: FLML). Bloxiverz was the first FDA-approved version of neostigmine, even though other versions of neostigmine have been on the market as unapproved, grandfathered products under the Food, Drug and Cosmetic Act of 1938 (The Pharma Letter June 6, 2013).

Said Darwazah, chairman and chief executive of Hikma, commented: “This approval demonstrates our strong regulatory capabilities and the successful execution of our strategy to develop a more differentiated injectable product portfolio."