HERTFORDSHIRE, England and
PITTSBURGH, March 20, 2018 /PRNewswire/ -- Global
pharmaceutical company Mylan N.V. (NASDAQ:MYL) today announced the
U.S. launch of the oncology drug Mitomycin for Injection USP, 5
mg/vial, 20 mg/vial and 40 mg/vial Single Dose Vials, a generic
version of the reference listed drug, Bristol Myers Squibb's
Mutamycin®. The product is used in combination with
other cancer medicines in the treatment of stomach and pancreatic
cancers.
Mylan is offering Mitomycin for Injection USP, 5 mg/vial, 20
mg/vial and 40 mg/vial Single Dose Vials to its hospital and
institutional customers after an Abbreviated New Drug Application
(ANDA) for the product was approved by the U.S. Food and Drug
Administration (FDA).
Mylan's injectables portfolio is one of the largest and most
diversified in the industry, with approximately 80 injectable
products in the U.S. across several therapeutic areas. Mylan is
also one of the largest suppliers of cancer medicines by volume in
the U.S.
U.S. sales for Mitomycin for Injection USP, 5 mg/vial, 20
mg/vial and 40 mg/vial Single Dose Vials were approximately
$59 million for the 12 months ending
Jan. 31, 2018, according to
IQVIA.
Currently, Mylan has 206 ANDAs pending
FDA approval representing approximately $93.8 billion in annual brand sales, according to
IQVIA. Forty-six of these pending ANDAs are potential first-to-file
opportunities, representing $42.2
billion in annual brand sales, for the 12 months
ending December 31, 2017, according to IQVIA.
According to its indication, Mitomycin Injection is not
recommended as a single-agent, primary therapy. It has been shown
to be useful in the therapy of disseminated adenocarcinoma of the
stomach or pancreas in proven combinations with other approved
chemotherapeutic agents and as palliative treatment when other
modalities have failed. Mitomycin is not recommended to replace
appropriate surgery and/or radiotherapy. (1)
(1) Mitomycin should be administered under the supervision of a
qualified physician experienced in the use of cancer
chemotherapeutic agents. Appropriate management of therapy and
complications is possible only when adequate diagnostic and
treatment facilities are readily available.
Bone marrow suppression, notably thrombocytopenia and
leukopenia, which may contribute to overwhelming infections in an
already compromised patient, is the most common and severe of the
toxic effects of mitomycin.
Hemolytic Uremic Syndrome (HUS) a serious complication of
chemotherapy, consisting primarily of macroangiopathic hemolytic
anemia, thrombocytopenia, and irreversible renal failure, has been
reported in patients receiving systemic mitomycin. The syndrome may
occur at any time during systemic therapy with mitomycin as a
single agent or in combination with other cytotoxic drugs; however,
most cases occur at doses ≥ 60 mg of mitomycin. Blood product
transfusion may exacerbate the symptoms associated with this
syndrome. The incidence of the syndrome has not been defined.
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.