HERTFORDSHIRE, England and
PITTSBURGH, June 2, 2016 /PRNewswire/ -- Mylan N.V. (NASDAQ,
TASE: MYL) today announced the U.S. launch of Propafenone
Hydrochloride Extended-Release Capsules USP, 225 mg, 325 mg, 425
mg, a generic version of GlaxoSmithKline's Rythmol® SR. 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 to prolong the time to recurrence of
symptomatic atrial fibrillation (AF) in patients with episodic
(most likely paroxysmal or persistent) AF who do not have
structural heart disease.(1)
Propafenone Hydrochloride Extended-Release Capsules USP, 225 mg,
325 mg, 425 mg, had U.S. sales of approximately $100.5 million for the 12 months ending
March 31, 2016, according to IMS
Health.
Currently, Mylan has 254 ANDAs pending FDA approval representing
$108.3 billion in annual brand sales,
according to IMS Health. Forty-three of these pending ANDAs are
potential first-to-file opportunities, representing $37.2 billion in annual brand sales, for the 12
months ending December 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 approximately 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) Antiarrhythmic agents should generally be avoided in
patients with non-life-threatening ventricular arrhythmias, even if
the patients are experiencing unpleasant, but not life-threatening,
symptoms or signs.
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SOURCE Mylan N.V.