Potiga (ezogabine) receives FDA approval


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Monday, 13 June 2011
Valeant Pharmaceuticals International Inc. (Meda’s partner for ezogabine - known as retigabine outside of the U.S.) has received approval from the U.S. Food and Drug Administration (FDA) for Potiga (ezogabine).

Potiga is approved for adjunctive treatment for adults with partial-onset seizures. It is the first approved potassium channel opener for this indication.
“We are glad to see Potiga approved in the U.S. and we hope that this novel treatment can be beneficial to patients”, said Anders L´┐Żnner, CEO Meda AB.


This FDA approval triggers a milestone payment to Meda of 6 MUSD. Meda is also entitled to receive royalties in the U.S. of 7% on net sales and other milestone payments related to future development of the product. GlaxoSmithKline is responsible for the global commercialization.
Trobalt (retigabine) was approved in Europe on 28 March 2011 and the launch by GlaxoSmithKline has already begun in Germany, the UK, Switzerland and Denmark. Meda will receive a royalty of between 6 - 8% in Europe.
Based on a press release circulated by Cisionwire

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