FDA-Approved Version of Neostigmine Heading to Market

Megan Brooks

Disclosures

June 04, 2013

The US Food and Drug Administration (FDA) has approved Flamel Technologies' new drug application for neostigmine (Bloxiverz), a cholinesterase inhibitor used routinely in anesthesia to reverse the effects of neuromuscular blocking agents after surgery, the company announced June 3.

Bloxiverz is the first FDA-approved version of neostigmine, which has been on the market as unapproved, grandfathered products under the Food, Drug, and Cosmetic Act of 1938.

Flamel expects to launch Bloxiverz in July 2013 in 0.5 and 1.0 mg/mL strengths.

The cost difference between the branded and generic version remains to be seen. "Flamel has not yet set a price on Bloxiverz. They will be setting a price in their discussions with the trade shortly," Bob Yedid, investor relations for Flamel Technologies, told Medscape Medical News by email.

"Based on our marketing experience, we believe that hospitals will welcome the addition of Bloxiverz as an FDA-approved version of neostigmine," Mike Anderson, Flamel's chief executive officer, said in statement.

He noted that unapproved versions of neostigmine have been in "short supply for nearly a year, which may add to the need for a reliable source of FDA-approved product."

As reported by Medscape Medical News, 98% of anesthesiologists responding to a 2012 survey by the American Society of Anesthesiologists reported experiencing a drug shortage, especially for fentanyl (66%), succinylcholine (21%), propofol (15%), and pancuronium (15%).

In a similar survey conducted by the society in 2011, the most frequent shortages were propofol (88%), succinylcholine (80%), neostigmine (52%), and epinephrine (17%).

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