LYON, FRANCE--(Marketwired - Jun 3, 2013) - Flamel Technologies (NASDAQ: FLML) today announced that the U.S. Food and Drug Administration (FDA) has approved the company's New Drug Application (NDA) for Bloxiverz? (neostigmine methylsulfate), a drug used intravenously in the operating room for the reversal of the effects of non-depolarizing neuromuscular blocking agents after surgery. Flamel expects to launch Bloxiverz? in July 2013 in 0.5 and 1.0 mg/mL strengths.
"We are extremely excited and pleased to receive this FDA approval for Bloxiverz?, the first product from the portfolio of Éclat products acquired in March 2012," said Mike Anderson, Chief Executive Officer of Flamel.
Bloxiverz? is the first FDA-approved version of neostigmine, even though other versions of neostigmine have been on the market as unapproved, grandfathered products under the Food, Drug and Cosmetic Act of 1938. Today, neostigmine is the most common agent used for the reversal of the effects of other agents used for neuromuscular blocks.
"Based on our marketing experience, we believe that hospitals will welcome the addition of Bloxiverz? as an FDA-approved version of neostigmine," continued Mr. Anderson. "In addition, 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."
Safety Information
The most common adverse reactions during treatment include bradycardia, nausea and vomiting. Atropine or glycopyrrolate should be administered prior to Bloxiverz to minimize the risk of bradycardia. Bloxiverz should be used with caution in patients with arrhythmias, recent acute coronary syndrome, vagotonia, hyperthyroidism, myasthenia gravis, epilepsy or peptic ulcer. Because of the possibility of hypersensitivity in an occasional patient, atropine and medications to treat anaphylaxis should always be readily available. Large doses of Bloxiverz administered when neuromuscular blockade is minimal can produce neuromuscular dysfunction. The dose of Bloxiverz should be reduced if recovery from neuromuscular blockade is nearly complete.
About Bloxiverz (neostigmine)
Bloxiverz (neostigmine) is a cholinesterase inhibitor that inhibits the hydrolysis of acetylcholine by competing with acetylcholine for attachment to acetylcholinesterase at sites of cholinergic transmission. It enhances cholinergic action by facilitating the transmission of impulses across neuromuscular junctions. Neostigmine's ability to increase synaptic acetylcholine levels underlies its effectiveness in reversing neuromuscular blockade produced by neuromuscular blocking agents used during surgery. Neostigmine does not readily cross the blood-brain barrier and therefore does not significantly affect cholinergic function in the central nervous system
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