BioCentury
ARTICLE | Clinical News

Bloxiverz neostigmine methylsulfate regulatory update

June 10, 2013 7:00 AM UTC

FDA approved an NDA for Bloxiverz neostigmine methylsulfate from Flamel to reverse the effects of non-depolarizing neuromuscular blocking agents after surgery. Flamel expects to launch the cholinesterase inhibitor next month in 0.5 and 1.0 mg/mL strengths. Flamel said the product is the first FDA-approved version of neostigmine, but noted that other versions of neostigmine have been on the market as unapproved, grandfathered products under the Food, Drug and Cosmetic Act of 1938. ...