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FDA Accepts NDA Filing for Retigabine
Date:12/30/2009

ALISO VIEJO, Calif., Dec. 30 /PRNewswire-FirstCall/ -- Valeant Pharmaceuticals International (NYSE: VRX) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) seeking marketing approval for the investigational drug retigabine, a neuronal potassium channel opener for the adjunctive treatment for adult epilepsy patients with partial-onset seizures. In addition, the European Medicines Agency (EMEA) confirmed on November 17, 2009 that the MAA was successfully validated thus enabling the MAA review to commence. The filings were submitted on October 30, 2009.

About Retigabine

Retigabine is a neuronal potassium channel opener currently in late-stage development as an adjunctive treatment for adult patients with partial-onset seizures. In Phase III epilepsy trials, retigabine reduced seizure rates compared to patients taking placebo. The most common adverse reactions (incidence greater than or equal to 5% and twice placebo) across all completed trials to date are dizziness, fatigue, confusional state, vertigo, tremor, coordination abnormal, diplopia (double vision), disturbance in attention, asthenia (weakness), and visual blurring.

Retigabine Important Note

As an investigational drug, retigabine has not been found by the Food and Drug Administration (FDA) or any other regulatory agency to be safe or effective in the treatment of any disease or illness. It may not be commercialized in the United States unless and until the FDA has approved a NDA. Similar restrictions apply in other countries.

Collaboration Agreement with GlaxoSmithKline

Valeant has a worldwide License and Collaboration Agreement with GlaxoSmithKline (NYSE:'/>"/>

SOURCE Valeant Pharmaceuticals International
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