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FDA approves Fresenius’ Neostigmine Methylsulfate Injection

The US Food and Drug Administration (FDA) has granted approval for Fresenius Kabi to market its Neostigmine Methylsulfate Injection, a cholinesterase inhibitor.

The injection is indicated for reversal of the effects of nondepolarizing neuromuscular blocking agents (NMBA) after surgery.

The drug is claimed to be the first approved by the FDA since the agency upgraded the status of the company’s pharmaceutical manufacturing facility in Grand Island, earlier this month.

The company’s facility had achieved voluntary action indicated (VAI) classification, which permits FDA approval of new products to be manufactured at the plant.

The company, which specializes in lifesaving medicines and technologies for infusion, transfusion and clinical nutrition, intends to start offering Neostigmine Methylsulfate Injection later in 2015.

Fresenius Kabi’s products and services are used to help care for critically and chronically ill patients.