Flamel Tech Receives FDA Approval for Bloxiverz
(NASDAQ: FLML) today announced that the U.S. Food and Drug
Administration (FDA) has approved the company's New Drug Application
(NDA) for Bloxiverz(TM) (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(TM) in July 2013 in 0.5 and 1.0
"We are extremely excited and pleased to receive this FDA approval
for Bloxiverz(TM), the first product from the portfolio of Eclat
products acquired in March 2012," said Mike Anderson, Chief Executive
Officer of Flamel.
Bloxiverz(TM) 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
"Based on our marketing experience, we believe that hospitals will
welcome the addition of Bloxiverz(TM) 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
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.
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