Valeant Pharmaceuticals International and GlaxoSmithKline PLC is seeking commercialization approval for its epilepsy treatment drug Potiga from the Food and Drug Administration.
Though on Monday the FDA authorities declared that the drug is effective for curing epilepsy, they are apprehensive regarding the drug’s side effect of urine retention. The advisory panel of FDA was handed over the task of appraising the drug. The agency will put forward its recommendations and result on August 30.
The agency wants to clarify if the urine disability caused by the drug can be treated. As told by the FDA agency, they will seek help from the outside health providers to confirm the safety of Potiga.
Dr. Russell Katz, Director of the FDA's neurology drugs division, expressed that the urinary problem caused by the drug Potiga can be rectified in some cases and not in all.
The drug, if gets sanction, will be sold jointly by Glaxo and Valeant and will be prescribed along with the other anti-seizure medicines that corrects the brain disorder caused by epilepsy.
As per the statements given by Valeant, the urinary problems caused by the use of the drug can be reversed by given specific treatments.
Valeant said, "There remains a significant unmet medical need for the effective treatment of patients who do not respond to currently marketed" epilepsy drugs”.