Mylan Inc. 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.
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