HERTFORDSHIRE, England and
PITTSBURGH, Dec. 17, 2018 /PRNewswire/ -- Global
pharmaceutical company Mylan N.V. (NASDAQ: MYL) today
announced the U.S. launch of Mesalamine Rectal Suppository, 1000
mg, the first generic version of Allergan's Canasa® Rectal
Suppository, 1000 mg. Mylan Pharmaceuticals received final approval
from the U.S. Food and Drug Administration (FDA) for its
Abbreviated New Drug Application (ANDA) for this product, which is
for the treatment of mildly to moderately active ulcerative
proctitis. According to the FDA approval letter, Mylan was the
first applicant to submit a substantially complete ANDA for
Mesalamine Rectal Suppository, 1000 mg, containing a Paragraph IV
certification, and is eligible for 180 days of generic drug
exclusivity.
U.S. sales for Mesalamine Rectal Suppository, 1000 mg, were
approximately $263 million for the 12
months ending October 31, 2018,
according to IQVIA.
Currently, Mylan has 168 ANDAs pending FDA approval representing
approximately $85.5 billion in annual
brand sales, according to IQVIA. Forty-four of these pending ANDAs
are potential first-to-file opportunities, representing
$50.4 billion in annual brand sales,
for the 12 months ending June 30,
2018, according to IQVIA.
About Mylan
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 more than 40% of people
being treated for HIV/AIDS globally 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 approximately 35,000-strong workforce is
dedicated to creating better health for a better world, one person
at a time. Learn more at Mylan.com. We routinely post information
that may be important to investors on our website at
investor.mylan.com.
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SOURCE Mylan N.V.