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Generic Version of Ditropan Granted Tentative Approval
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.