In a Wednesday statement, Valeant Pharmaceuticals International said that its marketing application for the investigational ‘Retigabine’ drug – for potentially treating adult epilespy patients with partial-onset seizures – is being reviewed by the US Food and Drug Administration (FDA), as well as the European Medicines Agency.

The specialty pharmaceutical firm further specified that while the FDA accepted its Retigabine-related review application on October 30, the European Union (EU) regulators accepted a November
17 filing.

Valeant has a global licensing and partnership accord on Retigabine with GlaxoSmithKline in the US, Canada, Australia, New Zealand, and Puerto Rico, over and above an exclusive license for developing and commercializing the drug in another places.

Noting that the FDA acceptance of the application prompts an $8 million landmark payment to Valeant’s partner on Retigabine, Meda Ab – a Swedish specialty pharmaceutical company, Valeant elaborated that late-stage trials have corroborated that the drug reduced seizure rates, vis-à-vis a placebo.

That Valeant is banking heavily on Retigabine to be its potential blockbuster drug is evident from the fact that three of the company’s top-selling drugs last year have either already lost patent protection or will lose it in 2010.

The company has slashed its research budget earlier this year to propel more partnerships, buyouts and stock buybacks. In addition, Valeant has also bought $97 million of stock - or 4 percent of the company - from its second-biggest shareholder.