Fresenius Kabi has received approval from the U.S. 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, N.Y., earlier this month. The company announced 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 nondepolarizing neuromuscular blocking agents (NMBA) after surgery. Fresenius Kabi expects to begin offering Neostigmine Methylsulfate Injection later this year.
