Mylan strikes deal for Parkinson's disease drug Stalevo

26 July 2013

US generics firm Mylan (Nasdaq: MYL) and Finland-based drugmaker Orion Corp (Nasdaq OMX Helsinki: ORNAV) have resolved litigation over Mylan’s Abbreviated New Drug Application filing with the US Food and Drug Administration for carbidopa/levodopa/entacapone tablets.

The settlement and license agreement is for the generic version of Orion’s Stalevo, to treat patients with idiopathic Parkinson's disease.

Under the terms of the settlement and license agreement, Mylan may launch an authorized generic version of Stalevo immediately and its own ANDA upon receiving final FDA approval. A joint statement said that the parties pending litigation will be dismissed. Terms and conditions were not disclosed, and the agreement is subject to review by the US Department of Justice and the Federal Trade Commission.

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