HERTFORDSHIRE, England and
PITTSBURGH, June 2, 2017 /PRNewswire/ -- Mylan N.V. (NASDAQ,
TASE: MYL) today announced the U.S. launch of Zoledronic Acid
Injection, 5 mg/100 mL Single Dose Vial, a generic version of
Novartis' Reclast® 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 indicated for
the treatment of Paget's disease of bone in men and women.
Zoledronic Acid Injection, 5 mg/100 mL Single Dose Vial, had
U.S. sales of approximately $22.1
million for the 12 months ending March 31, 2017, according to QuintilesIMS
Health.
Currently, Mylan has 234 ANDAs pending FDA approval representing
approximately $104 billion in annual
brand sales, according to QuintilesIMS Health. Forty-four of these
pending ANDAs are potential first-to-file opportunities,
representing $42.3 billion in annual
brand sales, for the 12 months ending December 31, 2016, according to QuintilesIMS
Health. Currently, one out of every 13 prescriptions filled in the
U.S. – brand-name or generic – is a Mylan product.
Mylan has one of the largest injectable portfolios in the
industry, with more than 100 products available to patients in the
U.S. across a broad array of therapeutic categories. Mylan's global
injectables manufacturing capacity has grown from 11 million units
in 2012 to 500 million units today.
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 approximately 7,500 marketed products around the
world, including antiretroviral therapies on which approximately
50% of people being treated for HIV/AIDS in the developing world
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 more than
35,000-strong workforce 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.