HERTFORDSHIRE, England and
PITTSBURGH, Oct. 18, 2018 /PRNewswire/ -- Global
pharmaceutical company Mylan N.V. (NASDAQ: MYL) today announced the
U.S. launch of Medroxyprogesterone Acetate Injectable Suspension
USP, 150 mg/mL Single-Dose Vial, a generic version of the brand
drug, Pfizer's Depo-Provera®.
Mylan is offering Medroxyprogesterone Acetate Injectable
Suspension USP, 150 mg/mL Single-Dose Vial to its institutional
customers after an Abbreviated New Drug Application (ANDA) for the
product was approved by the U.S. Food and Drug Administration
(FDA). Medroxyprogesterone Acetate Injectable (MPA) is indicated in
the prevention of pregnancy.
Mylan CEO Heather Bresch said,
"The launch of Medroxyprogesterone Acetate adds to Mylan's robust
portfolio of generic birth control medicines in the U.S. These
products are part of Mylan's growing women's healthcare offerings,
which include a variety of medicines to help women manage their
health across all the stages of their lives."
Women who use MPA may lose significant bone mineral density.
Bone loss is greater with increasing duration of use and may not be
completely reversible. It is unknown if use of MPA during
adolescence or early adulthood, a critical period of bone
accretion, will reduce peak bone mass and increase the risk for
osteoporotic fracture in later life. MPA should not be used
as a long-term birth control method (i.e., longer than 2 years)
unless other birth control methods are considered inadequate.
U.S. sales for MPA were approximately $181 million for the 12 months ending
July 31, 2018, according to
IQVIA.
Currently, Mylan has 179 ANDAs pending FDA approval representing
approximately $89.3 billion in annual
brand sales, according to IQVIA. Forty-four of these pending ANDAs
are potential first-to-file opportunities, representing
$51.6 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.