MYLAN'S OXYBUTYNIN CHLORIDE EXTENDED-RELEASE TABLETS RECEIVES TENTATIVE APPROVAL

Mylan Pharmaceuticals, the generic branch of Mylan Laboratories, has received tentative approval for its Oxybutynin Chloride extended-release tablets, 5 mg and 10 mg.

The tablets are the generic version of Alza's Ditropan (oxybutynin chloride) XL extended-release tablets, which is used to treat bladder control problems. Mylan believes it is the first generic drug company to file an abbreviated new drug application for generic Ditropan, which if true, would make the company eligible for 180 days of market exclusivity.