HERTFORDSHIRE, England and
PITTSBURGH, April 11, 2016 /PRNewswire/ -- Mylan N.V.
(NASDAQ, TASE: MYL) today announced the U.S. launch of Metoprolol
Tartrate Tablets USP, 37.5 mg and 75 mg, which is the generic
version of Novartis' Lopressor® Tablets. These strengths are the
first and only available intermediate dosage strengths between the
existing Metoprolol Tartrate Tablets USP strengths of 25 mg, 50 mg
and 100 mg. Mylan currently is the only manufacturer that offers
Metoprolol Tartrate Tablets in five strengths.
Mylan received final approval from the U.S. Food and Drug
Administration (FDA) for its Supplemental Abbreviated New Drug
Application (ANDA) for its Metoprolol Tartrate Tablets, 37.5 mg and
75 mg, which is indicated for the treatment of hypertension.(1)
Metoprolol Tartrate Tablets 25 mg, 50 mg and 100 mg strengths
had U.S. sales of approximately $68.9
million across all manufacturers for the 12 months ending
Feb. 29, 2016, according to IMS
Health.
Currently, Mylan has 265 ANDAs pending FDA approval representing
$110.3 billion in annual brand sales,
according to IMS Health. Forty-eight of these pending ANDAs are
potential first-to-file opportunities, representing $38.3 billion in annual brand sales, for the 12
months ending Dec. 31, 2015,
according to IMS Health.
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 1,400 generic and branded pharmaceuticals,
including antiretroviral therapies on which nearly 50% of people
being treated for HIV/AIDS in the developing world depend. We
market our products in approximately 165 countries and territories.
Our global R&D and manufacturing platform includes more than 50
facilities, and we are one of the world's largest producers of
active pharmaceutical ingredients. Every member of our nearly
35,000-strong workforce is dedicated to creating better health for
a better world, one person at a time. Learn more at mylan.com.
(1) Metoprolol is contraindicated in patients with cardiogenic
shock, overt cardiac failure and severe peripheral arterial
circulatory disorders. It is also contraindicated in patients
with certain cardiac conduction problems like bradycardia, second
and third degree heart block, and sick-sinus syndrome.
Metoprolol should be discontinued through a gradual reduction in
dosage, exacerbations of angina and myocardial infarctions have
occurred when metoprolol has been discontinued abruptly.
Patients should consult their physician if they have any questions
before starting or stopping metoprolol.
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SOURCE Mylan N.V.