Flamel Technologies Announces FDA Approval of Bloxiverz
03 6월 2013 - 8:30PM
Marketwired
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.
About Flamel Technologies. Flamel
Technologies SA's (NASDAQ: FLML) business model is to blend
high-value internally developed products with its leading drug
delivery capabilities. The Company has a proprietary pipeline of
niche specialty pharmaceutical products, while its drug delivery
platforms are focused on the goal of developing safer, more
efficacious formulations of drugs to address unmet medical needs.
Its partnered pipeline includes biological and chemical drugs
formulated with its Medusa® and Micropump® (and its applications to
the development of liquid formulations, i.e. LiquiTime™ and of
abuse-deterrent formulations Trigger Lock™) proprietary drug
delivery platforms. Several Medusa-based products have been
successfully tested in clinical trials. The Company has developed
products and manufactures Micropump-based microparticles under
FDA-audited GMP guidelines. Flamel Technologies has collaborations
with a number of leading pharmaceutical and biotechnology
companies, including GlaxoSmithKline (Coreg CR®, carvedilol
phosphate). The Company is headquartered in Lyon, France and has
operations in St. Louis, Missouri, USA, and manufacturing
facilities in Pessac, France. Additional information may be found
at www.flamel.com.
Safe Harbor This release contains
"forward-looking statements" within the meaning of the Private
Securities Litigation Reform Act of 1995, including certain plans,
expectations, goals and projections regarding financial results,
product developments and technology platforms. All statements that
are not clearly historical in nature are forward-looking, and the
words "anticipate," "assume," "believe," "expect," "estimate,"
"plan," "will," "may," and similar expressions are generally
intended to identify forward-looking statements. All
forward-looking statements involve risks, uncertainties and
contingencies, many of which are beyond our control that could
cause actual results to differ materially from those contemplated
in such forward-looking statements. These risks include risks that
the continued integration of Éclat Pharmaceuticals may not be
successful or that certain payment acceleration events may be
triggered; the reacquisition of the exclusive rights to develop and
commercialize IFN-β XL worldwide and identification of an
alternative strategic partner for the program may not be
successful; the identified opportunities will not result in
shorter-term, high value results; clinical trial results may not be
positive or our partners may decide not to move forward; products
in the development stage may not achieve scientific objectives or
milestones or meet stringent regulatory requirements; products in
development may not achieve market acceptance; competitive products
and pricing may hinder our commercial opportunities; we may not be
successful in identifying and pursuing opportunities to develop our
own product portfolio using Flamel's technology; and the risks
associated with our reliance on outside parties and key strategic
alliances. These and other risks are described more fully in
Flamel's Annual Report on Form 20-F for the year ended December 31,
2012 that has been filed with the Securities and Exchange
Commission (SEC). All forward-looking statements included in this
release are based on information available at the time of the
release. We undertake no obligation to update or alter our
forward-looking statements as a result of new information, future
events or otherwise.
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