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news.Mylan has confirmed that the company and its subsidiary Mylan Pharmaceuticals have been sued by Shionogi Pharma and CIMA LABS in connection with the filing of an abbreviated new drug application (ANDA) with the US Food and Drug Administration (FDA) for Prednisolone Sodium Phosphate Orally Disintegrating tablets, 10mg, 15mg and 30mg.
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Shionogi Pharma and CIMA LABS filed the lawsuit in the US District Court for the District of Delaware.
The product is the generic version of Orapred ODT, a corticosteroid indicated as an anti-inflammatory or immunosuppressive agent for the treatment of certain endocrine conditions and for palliation of certain neoplastic conditions.
Mylan believes it is the first company to have filed a substantially complete ANDA containing a Paragraph IV certification for the 10mg, 15mg and 30mg strengths and expects to qualify for 180 days of marketing exclusivity upon final FDA approval.