HERTFORDSHIRE, England and
PITTSBURGH, Sept. 17, 2019 /PRNewswire/ -- Mylan
N.V. (NASDAQ: MYL) today announced the U.S. launch of
Fulvestrant Injection, 250 mg/5 mL (50 mg/mL) per single-dose
prefilled syringe, a generic version of AstraZeneca's
Faslodex® Injection. 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 used to treat
certain types of advanced breast cancer in women who have
experienced menopause as monotherapy and in advanced or metastatic
breast cancer in combination with other products.
"Mylan's launch of Fulvestrant Injection represents an important
addition to our growing oncology portfolio and, more importantly,
expands the available treatment options for women who are facing
advanced or metastatic stages of breast cancer," said Mylan President Rajiv
Malik. "The launch also reinforces our scientific expertise
in bringing to market complex products, like injectables, which
further enhances our institutional business and exemplifies our
continued commitment to expanding access to medicine."
Mylan is dedicated to supporting patients at every stage of
cancer care with more than 50 oncology supportive care, therapeutic
and diagnostic products in the U.S.
Fulvestrant Injection, 250 mg/5 mL (50 mg/mL) per single-dose
prefilled syringe, had U.S. sales of approximately $550 million for the 12 months ending
June 30, 2019, according to
IQVIA.
Currently, Mylan has 151 ANDAs pending FDA approval representing
approximately $88.4 billion in annual
brand sales, according to IQVIA. Forty-four of these pending ANDAs
are potential first-to-file opportunities, representing
$59.2 billion in annual brand sales,
for the 12 months ending June 30,
2019, according to IQVIA.
Fulvestrant Injection is a prescription medicine used to treat
women with:
- Hormone receptor (HR)-positive, human epidermal growth factor
receptor 2 (HER2)-negative advanced breast cancer or breast cancer
that has spread to other parts of the body (metastatic), who have
gone through menopause, in combination with ribociclib as their
first endocrine therapy or after their cancer has progressed while
on prior endocrine therapy
- HR-positive, HER2-negative advanced breast cancer, who have
gone through menopause and have not been previously treated with
endocrine therapy
- HR-positive advanced breast cancer, who have gone through
menopause and whose disease has progressed after endocrine
therapy
- HR-positive, HER2-negative advanced or metastatic breast cancer
in combination with palbociclib or abemaciclib whose disease has
progressed after endocrine therapy
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.