Aliso Viejo-based drug maker Valeant Pharmaceuticals International said Wednesday its seizure drug retigabine is being reviewed for possible approval by U.S. and European regulators.
Valeant wants to sell retigabine as a treatment for adult epilepsy patients with partial onset seizures.
In September, Valeant said it planned to submit applications for retigabine with the Food and Drug Administration and the European Union’s European Medicines Agency.
The company’s announcement Wednesday confirmed its applications have been accepted by regulators.
Valeant and retigabine development partner GlaxoSmithKline PLC met with the FDA in August to talk about technical aspects of the regulatory filing.
The company acquired retigabine in 2005 through a $280 million buy of San Diego-based Xcel Pharmaceuticals Inc. It signed its development deal with Glaxo in 2008.
Some analysts believe much of Valeant’s fortunes rest on how retigabine does. The drug could see approval in 2010.
Valeant makes antiviral, skin and neurology drugs. They’re used to treat hepatitis C, skin cancer, epilepsy and other conditions.
The company has $800 million in projected sales for 2009 and a recent market value of $2.6 billion.
