FDA accepts NDA on Watson's OAB gel

The USA's Watson Pharmaceuticals says that its New Drug Application for oxybutynin chloride topical gel has been accepted for filing by the Food and Drug Administration. Watson is seeking marketing approval of this novel transdermal gel of oxybutynin HCl for the treatment of overactive bladder.

OTG is a clear, rapid-drying gel designed to produce consistent oxybutynin concentrations over a 24-hour period, the firm noted, adding that, by administering oxybutynin through the skin, it avoids first pass metabolism and the resultant high metabolite levels seen with oral oxybutynin dosing. A nickel-sized, one-gram unit dose of OTG, applied once daily, delivers about 4mg oxybutynin each day.