HERTFORDSHIRE, England and
PITTSBURGH, July 14, 2015 /PRNewswire/ -- Mylan N.V. (Nasdaq:
MYL) today announced the U.S. launch of Memantine Hydrochloride
Tablets USP, 5 mg and 10 mg, which is the generic version of
Forest's Namenda® Tablets. Mylan received final approval
from the U.S. Food and Drug Administration (FDA) for its
Abbreviated New Drug Application (ANDA) for this product, which is
indicated for the treatment of moderate to severe dementia of the
Alzheimer's type.
Memantine Hydrochloride Tablets USP, 5 mg and 10 mg, had U.S.
sales of approximately $1.4 billion
for the 12 months ending March 31,
2015, according to IMS Health. Mylan was one of the first
ANDA applicants to submit a substantially complete ANDA with a
paragraph IV certification and has therefore been granted 180 days
of shared generic drug marketing exclusivity.
Currently, Mylan has 270 ANDAs pending FDA approval representing
$107.2 billion in annual brand sales,
according to IMS Health. Forty-seven of these pending ANDAs are
potential first-to-file opportunities, representing $33.3 billion in annual brand sales, for the 12
months ending December 31, 2014,
according to IMS Health.
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 around 1,400 generic pharmaceuticals and several brand
medications. In addition, we offer a wide range of antiretroviral
therapies, upon which nearly 50% of HIV/AIDS patients in developing
countries depend. We also operate one of the largest active
pharmaceutical ingredient manufacturers and currently market
products in about 145 countries and territories. Our workforce of
approximately 30,000 people is dedicated to creating better health
for a better world, one person at a time. Learn more at
mylan.com.
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SOURCE Mylan N.V.