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Generic Version of Ditropan Granted Tentative Approval

HAYWARD, Calif.--(BUSINESS WIRE)--Feb. 2, 2005--IMPAX Laboratories, Inc. (NASDAQ:IPXL) today announced that the U.S. Food and Drug Administration (FDA) has granted tentative approval to the Company's Abbreviated New Drug Application (ANDA) for a generic version of Ditropan(R) XL (Oxybutynin Chloride) 5, 10 and 15 mg Extended Release Tablets. Alza Pharmaceuticals markets Ditropan XL for the treatment of urge urinary incontinence. U.S. sales of Ditropan XL were approximately $410 million in the 12 months ended November 30, 2004, according to NDCHealth.

Final approval is contingent upon the earlier of the resolution of 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. Final approval is also dependent upon FDA's evaluation of any new information subsequent to this tentative approval.

"This is our first ANDA approval this year," said Larry Hsu, Ph.D. IMPAX Laboratories, Inc. President. "We are pleased to add this to our product portfolio and will work diligently with our partner to launch this product upon final approval."

Source: IMPAX Laboratories, Inc.

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