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Ivax Glucophage XR Launch Halted By Purepac Exclusivity Suit

Executive Summary

Purepac's lawsuit over FDA's 180-day exclusivity determination on generic metformin extended-release challenges the agency's interpretation of first-to-file rights for amended ANDAs

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Glucophage XR Settlement: Purepac, Ivax Split Generic Profits For 180 Days

Ivax and Purepac's exclusivity rights settlement for a generic version of Glucophage XR means FDA has avoided a legal challenge to its interpretation of first-to-file requirements for new ANDAs compared to amended applications

Glucophage XR Settlement: Purepac, Ivax Split Generic Profits For 180 Days

Ivax and Purepac's exclusivity rights settlement for a generic version of Glucophage XR means FDA has avoided a legal challenge to its interpretation of first-to-file requirements for new ANDAs compared to amended applications

Purepac Glucophage XR ANDA Status Could Factor Into Injunction Ruling

A D.C. federal judge's decision on whether Ivax should be preliminarily enjoined from immediately marketing its generic version of Glucophage XR could hinge on the imminent approvability of Purepac's ANDA for metformin extended-release

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