IMPAX'S GENERIC DITROPAN XL APPROVED BY FDA

Impax Laboratories announced that the FDA has granted final approval to its abbreviated new drug application (ANDA) for a generic version of Ditropan XL (oxybutynin chloride) Extended-Release Tablets, 15 mg. The FDA also awarded the company first-to-file status and 180-day market exclusivity for this product. Alza Pharmaceuticals markets Ditropan XL for the treatment of urinary incontinence. U.S. sales of Ditropan XL 15 mg were approximately $58 million in the 12 months ending in August, Impax said, citing Wolters Kluwer Health.

The company's generic Ditropan XL 15 mg is one of 12 products covered under its strategic alliance with a subsidiary of Teva Pharmaceutical. Teva plans to begin marketing the product immediately.

Impax noted that it has received tentative approval for its 5- and 10-mg generic versions of Ditropan XL. Final approval is dependent on the expiration of any generic marketing exclusivity by other applicants, as well as the FDA's evaluation of any new information subsequent to the tentative approval.