HERTFORDSHIRE, England and PITTSBURGH, Dec. 29,
2016 /PRNewswire/ -- Mylan N.V. (NASDAQ, TASE: MYL),
today announced the U.S. launch of Methylphenidate Hydrochloride
Extended-Release Tablets USP, 18 mg, 27 mg, 36 mg and 54 mg, a
generic version of Janssen's Concerta® 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)
Mylan CEO Heather Bresch
commented, "The launch of generic Concerta® Tablets demonstrates
Mylan's leadership in complex development and manufacturing and in
bringing to market a broad portfolio of high quality generics. This
launch also further strengthens our robust portfolio of central
nervous system medications, which is the largest in the U.S. with
more than 100 products. We're excited about bringing another
generic in this therapeutic area to market and expanding access to
help patients."
Methylphenidate Hydrochloride Extended-Release Tablets USP, 18
mg, 27 mg, 36 mg and 54 mg, had U.S. sales of approximately
$1.59 billion for the 12 months
ending October 31, 2016, according to
IMS Health.
Currently, Mylan has more than 240 ANDAs pending FDA approval
representing approximately $95.6
billion in annual brand sales, according to IMS Health.
Forty-one of these pending ANDAs are potential first-to-file
opportunities, representing $32.5
billion in annual brand sales, for the 12 months ending
June 30, 2016, 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 2,700 generic and branded pharmaceuticals,
including antiretroviral therapies on which approximately 50% of
people being treated for HIV/AIDS worldwide depend. We market our
products in more than 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) Methylphenidate HCl ER Tablets USP, 18 mg, 27 mg, 36 mg and
54 mg should be given cautiously to patients with a history of drug
dependence or alcoholism. Chronic abusive use can lead to marked
tolerance and psychological dependence with varying degrees of
abnormal behavior.
To view the original version on PR Newswire,
visit:http://www.prnewswire.com/news-releases/mylan-launches-generic-concerta-tablets-300384105.html
SOURCE Mylan N.V.