Tentative FDA OK for IMPAX generic Ditropan

IMPAX Laboratories says that the US Food and Drug Administration has granted tentative approval for the company's Abbreviated New Drug Application for a generic version of Ditropan XL (oxybutynin chloride) 5mg, 10mg and 15mg extended-release tablets. Alza Pharmaceuticals markets Ditropan XL for the treatment of urge urinary incontinence and US sales of the drug were approximately $410.0 million in the 12 months ended November 30, 2004, according to NDCHealth.

Final approval is contingent upon the resolution of earlier pending patent-infringement litigation brought by Alza against IMPAX, or the expiration of the 30-month stay process under the Hatch-Waxman Amendments and the expiration of any generic marketing exclusivity.