Pharmaceutical giant GlaxoSmithKline has announced that it has managed to get the approval from the US Food and Drug Administration to use its epilepsy drug, Potiga, as an add-on treatment for partial onset seizures in the brain.
The drug will be jointly manufactured by GSK and its partner, Valeant Pharmaceuticals International, and has already gotten marketing approval in the European Union where it will be sold under the brand name Trobalt.
Potiga was expected to be approved by the FDA last year after it was backed by a panel of experts but the health agency asked for more information about the product. Though the FDA has finally approved the drug, it has also directed GSK to come up with risk-evaluation and mitigation strategy for doctors since Potiga was found to cause urinary retention in the clinical trials.
"We are so pleased to reach such an important milestone with the U.S. approval of Potiga by the FDA. We believe this product will play a needed role in the management of partial onset seizures in appropriate patients who are uncontrolled on their current medications", the head of research and development at Valeant, Susan Hall said.