PITTSBURGH, Oct. 30, 2014 /PRNewswire/ -- Mylan Inc. (Nasdaq:
MYL) today announced the U.S. launch of its Nevirapine
Extended-release tablets, 400 mg, which is the generic version of
Boehringer Ingelheim's Viramune XR®. 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 combination antiretroviral (ARV) treatment of
HIV-1 infection in adults and in children six to less than 18 years
of age(1). The launch of this product continues to
strengthen Mylan's growing ARV portfolio in the U.S. Mylan has
begun shipping product.
Nevirapine Extended-release tablets, 400 mg had U.S. sales of
approximately $61.9 million for the
12 months ending September 30, 2014,
according to IMS Health.
Currently, Mylan has 287 ANDAs pending FDA approval representing
$112.2 billion in annual brand sales,
according to IMS Health. Forty-three of these pending ANDAs are
potential first-to-file opportunities, representing $29.3 billion in annual brand sales, for the 12
months ending June 30, 2014,
according to IMS Health.
Mylan is a global pharmaceutical company committed to setting
new standards in health care. 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 1,300 generic pharmaceuticals and several
brand medications. In addition, we offer a wide range of
antiretroviral therapies, upon which approximately 40% of HIV/AIDS
patients in developing countries depend. We also operate one of the
largest active pharmaceutical ingredient manufacturers and
currently market products in approximately 140 countries and
territories. Our workforce of more than 20,000 people is dedicated
to improving the customer experience and increasing pharmaceutical
access to consumers around the world. Learn more at mylan.com.
(1) Severe, life-threatening, and in some cases fatal liver
toxicity and skin reactions have been reported with the use of
Nevirapine Extended-release tablets. Monitoring by your healthcare
provider is essential during the first 18 weeks of therapy.
SOURCE Mylan Inc.