FDA approves Fresenius Kabi's neostigmine methylsulfate injection

Fresenius Kabi, a unit of the Germany-headquartered Fresenius Group (FRE: Xetra), has received approval from the US Food and Drug Administration to market neostigmine methylsulfate injection.

This is the first Fresenius Kabi drug approved by the FDA since the agency upgraded the status of the company’s pharmaceutical manufacturing facility in Grand Island, New York, earlier this month. The company announced on January 12 that the facility had achieved voluntary action indicated (VAI) status from the FDA. VAI classification permits FDA approval of new products to be manufactured at the plant.

Neostigmine methylsulfate injection, a cholinesterase inhibitor, is indicated for reversal of the effects of non-depolarizing neuromuscular blocking agents (NMBA) after surgery. Fresenius Kabi expects to begin offering this product later this year.