Potiga
Generic name: ezogabine
Treatment for: Seizures
Retigabine NDA Accepted for Filing
FDA Accepts NDA Filing for Retigabine
ALISO VIEJO, Calif., Dec. 30 /PRNewswire-FirstCall/ -- Valeant Pharmaceuticals International 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:GSK) , to develop and commercialize retigabine. Valeant will collaborate with GSK on the development and marketing of retigabine in the United States, Australia, New Zealand, Canada and Puerto Rico (Collaboration Territory) and GSK has an exclusive license to develop and commercialize retigabine in countries outside of the Collaboration Territory and certain backup compounds to retigabine worldwide.
About Valeant
Valeant Pharmaceuticals International (NYSE:VRX) is a multinational specialty pharmaceutical company that develops, manufactures and markets a broad range of pharmaceutical products primarily in the areas of neurology and dermatology. More information about Valeant can be found at www.valeant.com.
CONTACT: Laurie W. Little of Valeant Pharmaceuticals, +1-949-461-6002,
laurie.little@valeant.com
Web Site: http://www.valeant.com/
* Retigabine is known as ezogabine within the United States.
Posted: December 2009
Related articles
- Valeant and GlaxoSmithKline Announce U.S. FDA Approval of Potiga (ezogabine) - June 13, 2011
- Regulatory Update - GSK and Valeant Respond to FDA on Ezogabine - April 18, 2011
- GSK and Valeant Announce Receipt of U.S. FDA Complete Response Letter for ezogabine - December 2, 2010
- Ezogabine, an Investigational Anti-Epileptic Drug, Receives Positive Vote from FDA Advisory Committee - August 12, 2010
Potiga (ezogabine) FDA Approval History
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