HERTFORDSHIRE, England and
PITTSBURGH, Nov. 19, 2015 /PRNewswire/ -- Mylan N.V.
(NASDAQ, TASE: MYL) today announced the U.S. launch of
Dextroamphetamine Saccharate, Amphetamine Aspartate,
Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets (mixed
salts of a single entity amphetamine product), 5 mg, 7.5 mg, 10 mg,
12.5 mg, 15 mg, 20 mg and 30 mg, which is the generic version of
Teva's Adderall® Tablets. 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 attention deficit hyperactivity
disorder (ADHD).(1)
Dextroamphetamine Saccharate, Amphetamine Aspartate,
Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets (mixed
salts of a single entity amphetamine product), 5 mg, 7.5 mg, 10 mg,
12.5 mg, 15 mg, 20 mg and 30 mg, had U.S. sales of approximately
$570.4 million for the 12 months
ending Sept. 30, 2015, according to
IMS Health.
Currently, Mylan has 253 ANDAs pending FDA approval representing
$100.8 billion in annual brand sales,
according to IMS Health. Fifty of these pending ANDAs are potential
first-to-file opportunities, representing $36.1 billion in annual brand sales, for the 12
months ending June 30, 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 around 1,400 generic pharmaceuticals and several brand
medications. In addition, we offer a wide range of antiretroviral
therapies, upon which nearly 50% of HIV/AIDS patients in developing
countries depend. We also operate one of the largest active
pharmaceutical ingredient manufacturers and currently market
products in about 145 countries and territories. Our workforce of
approximately 30,000 people 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 and prolonged
periods of use can lead to dependence. Misuse of amphetamine
may cause sudden death and serious cardiovascular adverse
events.
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SOURCE Mylan N.V.