HERTFORDSHIRE, England and
PITTSBURGH, Oct. 5, 2017 /PRNewswire/ -- Mylan N.V.
(NASDAQ, TASE: MYL) today announced the U.S. launch of Moxifloxacin
Hydrochloride in 0.8% Sodium Chloride Injection, 400 mg/250 mL (1.6
mg/mL) in 250 mL single-dose flexible bags, the first AP-rated
generic version of Bayer's Avelox®. The product is being
marketed and distributed by Mylan's subsidiary, Mylan
Institutional, under a final approval from the U.S. Food and Drug
Administration (FDA) for an Abbreviated New Drug Application (ANDA)
for this product, which is a fluoroquinolone antibacterial
indicated for treating infections in adults caused by designated
susceptible bacteria in community acquired pneumonia, skin and skin
structure infections, complicated intra-abdominal infections,
plague, acute bacterial sinusitis and acute bacterial exacerbation
of chronic bronchitis. (1)
Currently, Mylan has 225 ANDAs pending FDA approval,
representing approximately $92.5
billion in annual brand sales. Forty-four of these pending
ANDAs are potential first-to-file opportunities, representing
$41.9 billion in annual brand sales,
for the 12 months ending July 31,
2017, according to QuintilesIMS. Currently, one out of every
13 prescriptions filled in the U.S. – brand-name or generic – is a
Mylan product.
Mylan is a global pharmaceutical company committed to setting
new standards in healthcare. Working together around the world to
provide 7 billion people access to high quality medicine, we
innovate to satisfy unmet needs; make reliability and service
excellence a habit; do what's right, not what's easy; and impact
the future through passionate global leadership. We offer a growing
portfolio of more than 7,500 marketed products around the world,
including antiretroviral therapies on which approximately 50% of
people being treated for HIV/AIDS in the developing world depend.
We market our products in more than 165 countries and territories.
We are one of the world's largest producers of active
pharmaceutical ingredients. Every member of our more than
35,000-strong workforce is dedicated to creating better health for
a better world, one person at a time. Learn more at Mylan.com.
(1) Fluoroquinolones have been associated with disabling and
potentially irreversible serious adverse reactions that have
occurred together including: tendinitis and tendon rupture,
peripheral neuropathy and central nervous system effects.
Discontinue this product immediately and avoid the use of
fluoroquinolones in patients who experience any of these serious
adverse reactions. Fluoroquinolones may exacerbate muscle weakness
in patients with myasthenia gravis. Avoid this product in patients
with known history of myasthenia gravis. Because fluoroquinolones
have been associated with serious adverse reactions, reserve this
product for use in patients who have no alternative treatment
options for the following indications: acute bacterial sinusitis
and acute bacterial exacerbation of chronic bronchitis.
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SOURCE Mylan N.V.