Mylan Inc. announced the US 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 US 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 US 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.
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