IMPAX Laboratories, Inc. Receives Final FDA Approval for Generic Ditropan(R) XL 5 mg and 10 mg

HAYWARD, Calif.--(BUSINESS WIRE)--IMPAX Laboratories, Inc. (OTC: IPXL) (“IMPAX” or “the Company”) today announced that the U.S. Food and Drug Administration (FDA) has granted final approval of the Company's Abbreviated New Drug Application (ANDA) for generic versions of Ditropan® XL, (Oxybutynin Chloride) 5 mg and 10 mg Extended-release Tablets. Alza Pharmaceuticals markets Ditropan XL for the treatment of urge urinary incontinence. U.S. sales of both the branded and generic 5 mg and 10 mg dosage forms were approximately $233 million in the 12 months ended March 2007, according to Wolters Kluwer Health.
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