PITTSBURGH, Dec. 11, 2014 /PRNewswire/ -- Mylan Inc. (Nasdaq:
MYL) today announced the U.S. launch of its Prednisolone Sodium
Phosphate Orally Disintegrating Tablets, 10 mg, 15 mg, and 30 mg.
This product is the first generic version of Shionogi's Orapred
ODT®. Mylan received final approval from the U.S. Food and Drug
Administration (FDA) for its Abbreviated New Drug Application
(ANDA) for Prednisolone Sodium Phosphate Orally Disintegrating
Tablets, 10 mg, 15 mg, and 30 mg, and was awarded 180 days of
generic drug marketing exclusivity. This product is indicated as an
anti-inflammatory or immunosuppressive agent for certain
conditions; and also for the treatment of certain endocrine
conditions, and for palliation of certain neoplastic
conditions.
Prednisolone Sodium Phosphate Orally Disintegrating Tablets, 10
mg, 15 mg, and 30 mg, had U.S. sales of approximately $19.9 million for the 12 months ending
September 30, 2014, according to IMS
Health.
Currently, Mylan has 286 ANDAs pending FDA approval representing
$111.6 billion in annual brand sales,
according to IMS Health. Forty-five of these pending ANDAs are
potential first-to-file opportunities, representing $29.5 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.
To view the original version on PR Newswire,
visit:http://www.prnewswire.com/news-releases/mylan-launches-first-generic-version-of-orapred-odt-300008426.html
SOURCE Mylan Inc.