HERTFORDSHIRE, England and
PITTSBURGH, Aug. 1, 2016 /PRNewswire/ -- Mylan N.V.
(NASDAQ, TASE: MYL) today announced the U.S. launch of
Dextroamphetamine Sulfate Extended-release Capsules, 5 mg, 10 mg,
and 15 mg, a generic version of Amedra Pharmaceuticals LLC's
Dexedrine®. 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 in
narcolepsy and attention deficit disorder with hyperactivity as an
integral part of a total treatment program that typically includes
other measures (psychological, educational, social) for patients
(ages 6 years to 16 years) with this syndrome.(1)
Dextroamphetamine Sulfate Extended-release Capsules, 5 mg, 10
mg, and 15 mg, had U.S. sales of approximately $101.3 million for the 12 months ending
May 31, 2016, according to IMS
Health.
Currently, Mylan has 245 ANDAs pending FDA approval representing
$101.6 billion in annual brand sales,
according to IMS Health. Forty-one of these pending ANDAs are
potential first-to-file opportunities, representing $30.8 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
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.
(1) Amphetamines have a high potential for abuse. Administration
of amphetamines for prolonged periods of time may lead to drug
dependency and must be avoided. Particular attention should be paid
to the possibility of subjects obtaining amphetamines for
non-therapeutic use or distribution to others, and the drugs should
be prescribed or dispensed sparingly. Misuse of amphetamines may
cause sudden death and serious cardiovascular adverse events.
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SOURCE Mylan N.V.