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Actavis Waits On Alimta Hybrid Following FDA Approval

Teva’s Actavis Obtains NDA Approval

Executive Summary

FDA approval for a hybrid 505(b)(2) new drug application referencing Alimta has been awarded to Teva’s Actavis, with a key patent expiring in May 2022 proving a barrier to market entry. Teva was itself shot down over attempts to launch an ANDA product several years ago.

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